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EXCEL Clinical Trial (EXCEL)

Primary Purpose

Chronic Coronary Occlusion, Unprotected Left Main Coronary Artery Disease, Stent Thrombosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
CABG
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Coronary Occlusion focused on measuring Drug eluting stents, Stents, Unprotected Left Main Coronary Artery Disease, Coronary artery bypass graft surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

* Inclusion criteria for RCT:

  • Unprotected left main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) ≥70% requiring revascularization, or

  • ULMCA disease with agniographic DS >=50% but < 70% requiring revascularization, with one or more of the following present:

    • Non-invasive evidence of ischemia referable to a hemodynamically significant left main lesion (large area of ischemia in both the LAD and LCX territories, or in either the LAD or LCX territory in the absence of other obstructive coronary artery disease to explain the LAD or LCX defect), or stress-induced hypotension or stress-induced fall in LVEF, or stress-induced transient ischemic dilatation of the left ventricle or stress-induced thallium/technetiumlung uptake, and/or
    • IVUS minimum lumen area (MLA) <= 6.0mm2, and/or
    • Fractional Flow Reserve (FFR) <=0.80
  • Left Main Equivalent Disease
  • Clinical and anatomic eligibility for both PCI and CABG
  • Silent ischemia, stable angina, unstable angina or recent MI
  • Ability to sign informed consent and comply with all study procedures including follow-up for at least three years

Exclusion Criteria:

* Clinical exclusion criteria:

  • Prior PCI of the left main trunk at any time prior to randomization
  • Prior PCI of any other coronary artery lesions within one year prior to randomization
  • Prior CABG at any time prior to randomization
  • Need for any concomitant cardiac surgery other than CABG, or intent that if the subject randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
  • CK-MB greater than the local laboratory upper limit of normal or recent MI with CK-MB still elevated
  • Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
  • Subjects requiring or who may require additional surgery within one year
  • The presence of any clinical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present
  • The presence of any clinical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present
  • Pregnancy or intention to become pregnant
  • Non cardiac co-morbidities with life expectancy less than 3 years
  • Other investigational drug or device studies that have not reached their primary endpoint
  • Vulnerable population who in the judgment of the investigator is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention

Angiographic exclusion criteria:

  • Left main diameter stenosis <50%
  • SYNTAX score ≥33
  • Left main reference vessel diameter <2.25 mm or >4.25 mm
  • The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present
  • The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present

Sites / Locations

  • Abbott Vascular

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Percutaneous Coronary Intervention

Coronary Artery Bypass Graft

Arm Description

Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS

Those patients receiving CABG

Outcomes

Primary Outcome Measures

Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).

Secondary Outcome Measures

Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Death: Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met.
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Death: Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met.
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Death: Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met.
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With Protocol Defined MI
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Number of Participants With Protocol Defined MI
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Number of Participants With Protocol Defined MI
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Number of Participants With Protocol Defined MI
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Number of Participants With Protocol Defined MI
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Number of Participants With Protocol Defined MI
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Number of Participants With Protocol Defined MI
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Number of Participants With Protocol Defined MI
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Number of Participants With Disability Following Stroke Event
In case of an event of stroke disability at 90-days±2 weeks will be an overall measurement of severity of stroke as assessed by modified Rankin Scale (mRS) scale. Stroke disability will be classified using an adaptation of the modified Rankin Scale as follows, the assessment of which will be based on the Modified Rankin Disability Questionnaire. Scale 0; No stroke symptoms at all. (May have other complaints) Scale 1; No significant disability; symptoms present but no physical or other limitations. Scale 2; Slight disability; limitations in participation in usual social roles, but independent for activities of daily living (ADL) Scale 3; Some need for assistance but able to walk without assistance Scale 4; Moderately severe disability; need for assistance with some basic ADL, but not requiring constant care Scale 5; Severe disability; requiring constant nursing care and attention.
Number of Participants With Ischemia Driven Revascularizations (TLR,TVR and Non-TVR)
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Number of Participants With Ischemia Driven Revascularizations
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Number of Participants With Ischemia Driven Revascularizations
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Number of Participants With Ischemia Driven Revascularizations
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Number of Participants With Ischemia Driven Revascularizations
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Number of Participants With Ischemia Driven Revascularizations
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Number of Participants With Ischemia Driven Revascularizations
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Number of Participants With Ischemia Driven Revascularizations
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Number of Participants With All Revascularizations (Ischemia-driven or Non Ischemia-driven)
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Percentage of Participants With Major Adverse Events (MAE)
Composite of death, myocardial infarction, stroke, transfusion of ≥ 2 units of blood, major arrhythmia, unplanned coronary revascularization for ischemia, any unplanned surgery or radiologic procedure, renal failure, sternal wound dehiscence, infection requiring antibiotics for treatment, intubation for > 48 hours, or post-pericardiotomy syndrome.
Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable
Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable
Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable
Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable
Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable
Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Number of Participants With Graft Stenosis or Occlusion
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Graft Stenosis or Occlusion
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Graft Stenosis or Occlusion
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Graft Stenosis or Occlusion
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Graft Stenosis or Occlusion
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Graft Stenosis or Occlusion
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Graft Stenosis or Occlusion
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Graft Stenosis or Occlusion
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Requirement for Blood Product Transfusion
All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].
Number of Participants With Requirement for Blood Product Transfusion
All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].
Number of Participants With Requirement for Blood Product Transfusion
All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].
Number of Participants With Requirement for Blood Product Transfusion
All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].
Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding
Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.
Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding
Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.
Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding
Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.
Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding
Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.
Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding
Type 0: No bleeding Type 1: Bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: Any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: Fatal bleeding
Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding
Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding
Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding
Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding
Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding
Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding
Number of Participants With Major Adverse Events (MAE)
death myocardial infarction stroke Transfusion of ≥2 units of blood TIMI major or minor bleeding major arrhythmia unplanned coronary revascularization for ischemia any unplanned surgery or therapeutic radiologic procedure renal failure sternal wound dehiscence infection requiring antibiotics for treatment intubation for > 48 hours post-pericardiotomy syndrome
Number of Participants With Complete Revascularization (Residual = 0)
Complete anatomic revascularization requires revascularization of all vessels ≥2.0 mm reference vessel diameter with a DS ≥60% (both as measured by core angiographic laboratory analysis). -While this will be the pre-specified criteria for anatomically significant lesions, sensitivity analysis will be performed using different criteria (e.g. ≥2.5 mm vessels, DS ≥70%, etc.) From the baseline angiogram, the angiographic core lab will identify and designate those lesions and vessels requiring revascularization in all subjects according to this definition, prior to knowledge of the extent of actual revascularization. Following PCI, the angiographic core lab will determine the extent of revascularization (vessels with TIMI 2or3 flow post procedure with a core laboratory DS <50% considered successfully revascularized). Following CABG, the angiographic core lab will determine the extent of revascularization or if there is a repeat angiogram during the index hospitalization.
Number of Participants With Definite Stent Thrombosis (ST) or Symptomatic Graft Occlusion
- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

Full Information

First Posted
September 16, 2010
Last Updated
March 24, 2020
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01205776
Brief Title
EXCEL Clinical Trial
Acronym
EXCEL
Official Title
Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 29, 2010 (Actual)
Primary Completion Date
May 3, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the United States [OUS] only]) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Coronary Occlusion, Unprotected Left Main Coronary Artery Disease, Stent Thrombosis, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
Keywords
Drug eluting stents, Stents, Unprotected Left Main Coronary Artery Disease, Coronary artery bypass graft surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1905 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous Coronary Intervention
Arm Type
Active Comparator
Arm Description
Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
Arm Title
Coronary Artery Bypass Graft
Arm Type
Active Comparator
Arm Description
Those patients receiving CABG
Intervention Type
Device
Intervention Name(s)
Percutaneous Coronary Intervention
Intervention Description
Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
Intervention Type
Procedure
Intervention Name(s)
CABG
Intervention Description
Those patients receiving CABG
Primary Outcome Measure Information:
Title
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
In-hospital (≤ 7 days of index-procedure)
Title
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
30 days
Title
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
0 to 6 months
Title
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
0 to 1 year
Title
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
0 to 2 years
Title
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
0 to 3 years
Title
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
0 to 4 years
Title
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
0 to 5 years
Title
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
In-hospital (≤ 7 days of index-procedure)
Title
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
0 to 30 days
Title
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
0 to 6 months
Title
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
0 to 1 year
Title
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description
All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).
Time Frame
0 to 2 years
Title
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description
Death: Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met.
Time Frame
0 to 3 years
Title
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description
Death: Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met.
Time Frame
0 to 4 years
Title
Number of Participants With Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia
Description
Death: Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery). Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Myocardial Infarction (MI) -Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Unplanned revascularization for ischemia: Any repeat revascularization of either a target vessel or non-target vessel with any of the above criteria for ischemia met.
Time Frame
0 to 5 years
Title
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
In-hospital (≤ 7 days of index-procedure)
Title
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
0 to 30 days
Title
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
0 to 6 months
Title
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
0 to 1 year
Title
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
0 to 2 years
Title
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
0 to 3 years
Title
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
0 to 4 years
Title
Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death)
Description
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
0 to 5 years
Title
Number of Participants With Protocol Defined MI
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame
In-hospital (≤ 7 days of post index procedure)
Title
Number of Participants With Protocol Defined MI
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame
0 to 30 days
Title
Number of Participants With Protocol Defined MI
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame
0 to 6 months
Title
Number of Participants With Protocol Defined MI
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame
0 to 1 year
Title
Number of Participants With Protocol Defined MI
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame
0 to 2 years
Title
Number of Participants With Protocol Defined MI
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame
0 to 3 years
Title
Number of Participants With Protocol Defined MI
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame
0 to 4 years
Title
Number of Participants With Protocol Defined MI
Description
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time Frame
0 to 5 years
Title
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame
In-hospital (≤ 7 days of index-procedure)
Title
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame
0 to 30 days
Title
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame
0 to 6 months
Title
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame
0 to 1 year
Title
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame
0 to 2 years
Title
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame
0 to 3 years
Title
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame
0 to 4 years
Title
Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke)
Description
Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection). Ischemic (Non-hemorrhagic): A stroke caused by an arterial obstruction due to either a thrombotic (e.g., large vessel disease/atherosclerotic or small vessel disease/lacunar) or embolic etiology. Hemorrhagic: A stroke due to a hemorrhage in the brain as documented by neuroimaging or autopsy. This category will include strokes due to primary intracerebral hemorrhage (intraparenchymal or intraventricular), ischemic strokes with hemorrhagic transformation (i.e., no evidence of hemorrhage on an initial imaging study but appearance on a subsequent scan), subdural hematoma,* and primary subarachnoid hemorrhage. All subdural hematomas that develop during the clinical trial should be recorded and classified as either traumatic versus nontraumatic.
Time Frame
0 to 5 years
Title
Number of Participants With Disability Following Stroke Event
Description
In case of an event of stroke disability at 90-days±2 weeks will be an overall measurement of severity of stroke as assessed by modified Rankin Scale (mRS) scale. Stroke disability will be classified using an adaptation of the modified Rankin Scale as follows, the assessment of which will be based on the Modified Rankin Disability Questionnaire. Scale 0; No stroke symptoms at all. (May have other complaints) Scale 1; No significant disability; symptoms present but no physical or other limitations. Scale 2; Slight disability; limitations in participation in usual social roles, but independent for activities of daily living (ADL) Scale 3; Some need for assistance but able to walk without assistance Scale 4; Moderately severe disability; need for assistance with some basic ADL, but not requiring constant care Scale 5; Severe disability; requiring constant nursing care and attention.
Time Frame
90 days ± 2 weeks
Title
Number of Participants With Ischemia Driven Revascularizations (TLR,TVR and Non-TVR)
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame
In-hospital (≤ 7 days of index-procedure)
Title
Number of Participants With Ischemia Driven Revascularizations
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame
0 to 30 days
Title
Number of Participants With Ischemia Driven Revascularizations
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame
0 to 6 months
Title
Number of Participants With Ischemia Driven Revascularizations
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame
0 to 1 year
Title
Number of Participants With Ischemia Driven Revascularizations
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame
0 to 2 years
Title
Number of Participants With Ischemia Driven Revascularizations
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame
0 to 3 years
Title
Number of Participants With Ischemia Driven Revascularizations
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame
0 to 4 years
Title
Number of Participants With Ischemia Driven Revascularizations
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; or Ischemic ECG changes at rest in a distribution consistent with the target vessel; or Typical ischemic symptoms referable to the target lesion; or IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; or Fractional Flow Reserve (FFR) of the target lesion ≤ 0.80
Time Frame
0 to 5 years
Title
Number of Participants With All Revascularizations (Ischemia-driven or Non Ischemia-driven)
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame
In-hospital (≤ 7 days of index-procedure)
Title
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame
0 to 30 days
Title
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame
0 to 6 months
Title
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame
0 to 1 year
Title
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame
0 to 2 years
Title
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame
0 to 3 years
Title
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame
0 to 4 years
Title
Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven)
Description
A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met: A positive functional study corresponding to the area served by the target lesion; Ischemic ECG changes at rest in a distribution consistent with the target vessel; Typical ischemic symptoms referable to the target lesion; IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the plaque burden must also be ≥ 60%; FFR of the target lesion ≤ 0.80 A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.
Time Frame
0 to 5 years
Title
Percentage of Participants With Major Adverse Events (MAE)
Description
Composite of death, myocardial infarction, stroke, transfusion of ≥ 2 units of blood, major arrhythmia, unplanned coronary revascularization for ischemia, any unplanned surgery or radiologic procedure, renal failure, sternal wound dehiscence, infection requiring antibiotics for treatment, intubation for > 48 hours, or post-pericardiotomy syndrome.
Time Frame
In-hospital
Title
Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable
Description
Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time Frame
Early (0-30 days)
Title
Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable
Description
Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time Frame
Acute (<= 24 hours)
Title
Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable
Description
Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time Frame
Subacute (1-30 days)
Title
Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable
Description
Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time Frame
Late (>30 days - 1 year)
Title
Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable
Description
Definite stent thrombosis occurred by either angiographic/pathologic confirmation of stent thrombosis. Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive thrombus Occlusive thrombus. Pathological confirmation: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable stent thrombosis may occur after intracoronary stenting due to: Unexplained death within first 30 days Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause.
Time Frame
Very late (>1 year)
Title
Number of Participants With Graft Stenosis or Occlusion
Description
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
In-hospital (≤ 7 days of index-procedure)
Title
Number of Participants With Graft Stenosis or Occlusion
Description
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
0 to 30 days
Title
Number of Participants With Graft Stenosis or Occlusion
Description
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
0 to 6 months
Title
Number of Participants With Graft Stenosis or Occlusion
Description
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
0 to 1 year
Title
Number of Participants With Graft Stenosis or Occlusion
Description
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
0 to 2 years
Title
Number of Participants With Graft Stenosis or Occlusion
Description
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
0 to 3 years
Title
Number of Participants With Graft Stenosis or Occlusion
Description
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
0 to 4 years
Title
Number of Participants With Graft Stenosis or Occlusion
Description
Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
0 to 5 years
Title
Number of Participants With Requirement for Blood Product Transfusion
Description
All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].
Time Frame
30 days
Title
Number of Participants With Requirement for Blood Product Transfusion
Description
All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].
Time Frame
3 years
Title
Number of Participants With Requirement for Blood Product Transfusion
Description
All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].
Time Frame
4 years
Title
Number of Participants With Requirement for Blood Product Transfusion
Description
All TIMI definitions take into account blood transfusions, so that hemoglobin and hematocrit values are adjusted by 1 g/dl or 3%, respectively, for each unit of blood transfused. Therefore, the true change in hemoglobin or hematocrit if there has been an intervening transfusion between two blood measurements is calculated as follows: Δ Hemoglobin = [baseline Hgb - post-transfusion Hgb] + [number of transfused units]; Δ Hematocrit = [baseline Hct - post-transfusion Hct] + [number of transfused units X 3].
Time Frame
5 years
Title
Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding
Description
Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.
Time Frame
30 days
Title
Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding
Description
Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.
Time Frame
3 years
Title
Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding
Description
Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.
Time Frame
4 years
Title
Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding
Description
Bleeding will be classified by the TIMI hemorrhage classification Severity: Major: Intracranial hemorrhage A ≥5 g/dL decrease in the hemoglobin concentration A ≥15% absolute decrease in the hematocrit Minor: Observed blood loss: A ≥ 3 g/dL decrease in the hemoglobin concentration A ≥ 10% absolute decrease in the hematocrit No observed blood loss: A ≥ 4 g/dL decrease in the hemoglobin concentration A ≥ 12% absolute decrease in the hematocrit Minimal: • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.
Time Frame
5 years
Title
Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding
Description
Type 0: No bleeding Type 1: Bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: Any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: Fatal bleeding
Time Frame
30 days
Title
Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding
Description
Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding
Time Frame
3 years
Title
Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding
Description
Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding
Time Frame
4 years
Title
Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding
Description
Type 0: no bleeding Type 1: bleeding that is not actionable&does not cause the patient to seek unscheduled performance of studies,hospitalization,or treatment by a healthcare professional Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3,4,or 5 but does meet at least 1 of the following criteria:requiring nonsurgical, medical intervention by a healthcare professional; leading to hospitalization or increased level of care; prompting evaluation. Type 3 Type 3a Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL Any transfusion with overt bleeding Type 3b Overt bleeding plus hemoglobin drop ≥5 g/dL* Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring intravenous vasoactive agents Type 3c Intracranial hemorrhage Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision Type 4: CABG-related bleeding Type 5: fatal bleeding
Time Frame
5 years
Title
Number of Participants With Major Adverse Events (MAE)
Description
death myocardial infarction stroke Transfusion of ≥2 units of blood TIMI major or minor bleeding major arrhythmia unplanned coronary revascularization for ischemia any unplanned surgery or therapeutic radiologic procedure renal failure sternal wound dehiscence infection requiring antibiotics for treatment intubation for > 48 hours post-pericardiotomy syndrome
Time Frame
30 days
Title
Number of Participants With Complete Revascularization (Residual = 0)
Description
Complete anatomic revascularization requires revascularization of all vessels ≥2.0 mm reference vessel diameter with a DS ≥60% (both as measured by core angiographic laboratory analysis). -While this will be the pre-specified criteria for anatomically significant lesions, sensitivity analysis will be performed using different criteria (e.g. ≥2.5 mm vessels, DS ≥70%, etc.) From the baseline angiogram, the angiographic core lab will identify and designate those lesions and vessels requiring revascularization in all subjects according to this definition, prior to knowledge of the extent of actual revascularization. Following PCI, the angiographic core lab will determine the extent of revascularization (vessels with TIMI 2or3 flow post procedure with a core laboratory DS <50% considered successfully revascularized). Following CABG, the angiographic core lab will determine the extent of revascularization or if there is a repeat angiogram during the index hospitalization.
Time Frame
At Baseline
Title
Number of Participants With Definite Stent Thrombosis (ST) or Symptomatic Graft Occlusion
Description
- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
In-hospital (≤ 7 days of post index procedure)
Title
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
Description
- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
1 year
Title
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
Description
- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
2 years
Title
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
Description
- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
3 years
Title
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
Description
- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
4 years
Title
Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion
Description
- Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: Acute onset of ischemic symptoms at rest New ischemic ECG changes Typical rise&fall in cardiac biomarkers Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. -Symptomatic graft occlusion: Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: * Inclusion criteria for RCT: Unprotected left main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) ≥70% requiring revascularization, or ULMCA disease with agniographic DS >=50% but < 70% requiring revascularization, with one or more of the following present: Non-invasive evidence of ischemia referable to a hemodynamically significant left main lesion (large area of ischemia in both the LAD and LCX territories, or in either the LAD or LCX territory in the absence of other obstructive coronary artery disease to explain the LAD or LCX defect), or stress-induced hypotension or stress-induced fall in LVEF, or stress-induced transient ischemic dilatation of the left ventricle or stress-induced thallium/technetiumlung uptake, and/or IVUS minimum lumen area (MLA) <= 6.0mm2, and/or Fractional Flow Reserve (FFR) <=0.80 Left Main Equivalent Disease Clinical and anatomic eligibility for both PCI and CABG Silent ischemia, stable angina, unstable angina or recent MI Ability to sign informed consent and comply with all study procedures including follow-up for at least three years Exclusion Criteria: * Clinical exclusion criteria: Prior PCI of the left main trunk at any time prior to randomization Prior PCI of any other coronary artery lesions within one year prior to randomization Prior CABG at any time prior to randomization Need for any concomitant cardiac surgery other than CABG, or intent that if the subject randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed CK-MB greater than the local laboratory upper limit of normal or recent MI with CK-MB still elevated Subjects unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year Subjects requiring or who may require additional surgery within one year The presence of any clinical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present The presence of any clinical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present Pregnancy or intention to become pregnant Non cardiac co-morbidities with life expectancy less than 3 years Other investigational drug or device studies that have not reached their primary endpoint Vulnerable population who in the judgment of the investigator is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention Angiographic exclusion criteria: Left main diameter stenosis <50% SYNTAX score ≥33 Left main reference vessel diameter <2.25 mm or >4.25 mm The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present The presence of specific coronary lesion characteristics or other cardiac condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregg W Stone, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick W Serruys, MD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Sabik, MD
Organizational Affiliation
Cleveland Clinical Main Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A. Pieter Kappetein, MD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Vascular
City
Santa Clara
State/Province
California
ZIP/Postal Code
95054
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35861797
Citation
Magnuson EA, Chinnakondepalli K, Vilain K, Serruys PW, Sabik JF, Kappetein AP, Stone GW, Cohen DJ; EXCEL Investigators. Cost-Effectiveness of Percutaneous Coronary Intervention Versus Bypass Surgery for Patients With Left Main Disease: Results From the EXCEL Trial. Circ Cardiovasc Interv. 2022 Jul;15(7):e011981. doi: 10.1161/CIRCINTERVENTIONS.122.011981. Epub 2022 Jul 19.
Results Reference
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PubMed Identifier
34212863
Citation
Myat A, Hildick-Smith D, de Belder AJ, Trivedi U, Crowley A, Morice MC, Kandzari DE, Lembo NJ, Brown WM III, Serruys PW, Kappetein AP, Sabik JF III, Stone G. Geographical variations in left main coronary artery revascularisation: a prespecified analysis of the EXCEL trial. EuroIntervention. 2022 Jan 28;17(13):1081-1090. doi: 10.4244/EIJ-D-21-00338.
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PubMed Identifier
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Citation
Gregson J, Stone GW, Ben-Yehuda O, Redfors B, Kandzari DE, Morice MC, Leon MB, Kosmidou I, Lembo NJ, Brown WM 3rd, Karmpaliotis D, Banning AP, Pomar J, Sabate M, Simonton CA, Dressler O, Kappetein AP, Sabik JF 3rd, Serruys PW, Pocock SJ. Implications of Alternative Definitions of Peri-Procedural Myocardial Infarction After Coronary Revascularization. J Am Coll Cardiol. 2020 Oct 6;76(14):1609-1621. doi: 10.1016/j.jacc.2020.08.016.
Results Reference
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32216919
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Gaba P, Serruys PW, Sabik JF 3rd, Kappetein AP, Chen S, Morice MC, Kandzari DE, Crowley A, Mehran R, Stone GW. Effect of Baseline Anemia on Outcomes After Left Main Coronary Revascularization. J Am Coll Cardiol. 2020 Mar 31;75(12):1493-1495. doi: 10.1016/j.jacc.2020.01.037. No abstract available.
Results Reference
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PubMed Identifier
32043709
Citation
Thuijs DJFM, Milojevic M, Stone GW, Puskas JD, Serruys PW, Sabik JF 3rd, Dressler O, Crowley A, Head SJ, Kappetein AP. Impact of left ventricular ejection fraction on clinical outcomes after left main coronary artery revascularization: results from the randomized EXCEL trial. Eur J Heart Fail. 2020 May;22(5):871-879. doi: 10.1002/ejhf.1681. Epub 2020 Feb 11.
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Results Reference
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PubMed Identifier
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PubMed Identifier
31562798
Citation
Stone GW, Kappetein AP, Sabik JF, Pocock SJ, Morice MC, Puskas J, Kandzari DE, Karmpaliotis D, Brown WM 3rd, Lembo NJ, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman PE, Bochenek A, Schampaert E, Page P, Modolo R, Gregson J, Simonton CA, Mehran R, Kosmidou I, Genereux P, Crowley A, Dressler O, Serruys PW; EXCEL Trial Investigators. Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease. N Engl J Med. 2019 Nov 7;381(19):1820-1830. doi: 10.1056/NEJMoa1909406. Epub 2019 Sep 28. Erratum In: N Engl J Med. 2020 Mar 12;382(11):1078.
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PubMed Identifier
31495220
Citation
Shlofmitz E, Genereux P, Chen S, Dressler O, Ben-Yehuda O, Morice MC, Puskas JD, Taggart DP, Kandzari DE, Crowley A, Redfors B, Mehdipoor G, Kappetein AP, Sabik JF 3rd, Serruys PW, Stone GW. Left Main Coronary Artery Disease Revascularization According to the SYNTAX Score. Circ Cardiovasc Interv. 2019 Sep;12(9):e008007. doi: 10.1161/CIRCINTERVENTIONS.118.008007. Epub 2019 Sep 9.
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PubMed Identifier
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Results Reference
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PubMed Identifier
30999989
Citation
Modolo R, Chichareon P, Kogame N, Dressler O, Crowley A, Ben-Yehuda O, Puskas J, Banning A, Taggart DP, Kappetein AP, Sabik JA, Onuma Y, Stone GW, Serruys PW. Contemporary Outcomes Following Coronary Artery Bypass Graft Surgery for Left Main Disease. J Am Coll Cardiol. 2019 Apr 23;73(15):1877-1886. doi: 10.1016/j.jacc.2018.12.090.
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PubMed Identifier
30947913
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Milojevic M, Serruys PW, Sabik JF 3rd, Kandzari DE, Schampaert E, van Boven AJ, Horkay F, Ungi I, Mansour S, Banning AP, Taggart DP, Sabate M, Gershlick AH, Bochenek A, Pomar J, Lembo NJ, Noiseux N, Puskas JD, Crowley A, Kosmidou I, Mehran R, Ben-Yehuda O, Genereux P, Pocock SJ, Simonton CA, Stone GW, Kappetein AP. Bypass Surgery or Stenting for Left Main Coronary Artery Disease in Patients With Diabetes. J Am Coll Cardiol. 2019 Apr 9;73(13):1616-1628. doi: 10.1016/j.jacc.2019.01.037.
Results Reference
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PubMed Identifier
30596978
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PubMed Identifier
30354633
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Kandzari DE, Gershlick AH, Serruys PW, Leon MB, Morice MC, Simonton CA, Lembo NJ, Banning AP, Merkely B, van Boven AJ, Ungi I, Kappetein AP, Sabik JF 3rd, Genereux P, Dressler O, Stone GW. Outcomes Among Patients Undergoing Distal Left Main Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2018 Oct;11(10):e007007. doi: 10.1161/CIRCINTERVENTIONS.118.007007.
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30092952
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Giustino G, Mehran R, Serruys PW, Sabik JF 3rd, Milojevic M, Simonton CA, Puskas JD, Kandzari DE, Morice MC, Taggart DP, Gershlick AH, Genereux P, Zhang Z, McAndrew T, Redfors B, Ragosta M 3rd, Kron IL, Dressler O, Leon MB, Pocock SJ, Ben-Yehuda O, Kappetein AP, Stone GW. Left Main Revascularization With PCI or CABG in Patients With Chronic Kidney Disease: EXCEL Trial. J Am Coll Cardiol. 2018 Aug 14;72(7):754-765. doi: 10.1016/j.jacc.2018.05.057.
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PubMed Identifier
29666071
Citation
Redfors B, Chen S, Crowley A, Ben-Yehuda O, Gersh BJ, Lembo NJ, Brown WM 3rd, Banning AP, Taggart DP, Serruys PW, Kappetein AP, Sabik JF 3rd, Stone GW. B-Type Natriuretic Peptide Assessment in Patients Undergoing Revascularization for Left Main Coronary Artery Disease: Analysis From the EXCEL Trial. Circulation. 2018 Jul 31;138(5):469-478. doi: 10.1161/CIRCULATIONAHA.118.033631.
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Kosmidou I, Chen S, Kappetein AP, Serruys PW, Gersh BJ, Puskas JD, Kandzari DE, Taggart DP, Morice MC, Buszman PE, Bochenek A, Schampaert E, Page P, Sabik JF 3rd, McAndrew T, Redfors B, Ben-Yehuda O, Stone GW. New-Onset Atrial Fibrillation After PCI or CABG for Left Main Disease: The EXCEL Trial. J Am Coll Cardiol. 2018 Feb 20;71(7):739-748. doi: 10.1016/j.jacc.2017.12.012.
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Stone GW, Sabik JF, Serruys PW, Simonton CA, Genereux P, Puskas J, Kandzari DE, Morice MC, Lembo N, Brown WM 3rd, Taggart DP, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman P, Bochenek A, Schampaert E, Page P, Dressler O, Kosmidou I, Mehran R, Pocock SJ, Kappetein AP; EXCEL Trial Investigators. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease. N Engl J Med. 2016 Dec 8;375(23):2223-2235. doi: 10.1056/NEJMoa1610227. Epub 2016 Oct 31. Erratum In: N Engl J Med. 2019 Oct 31;381(18):1789.
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EXCEL Clinical Trial

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