search
Back to results

XIENCE 28 Global Study

Primary Purpose

Bleeding Disorder, Stroke, Ischemic, Stroke Hemorrhagic

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
XIENCE
DAPT
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding Disorder focused on measuring XIENCE, High bleeding risk (HBR), Dual antiplatelet therapy (DAPT), Coronary Artery Disease, Drug eluting stent (DES)

Eligibility Criteria

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

Inclusion Criteria:

  1. Subject is considered at HBR, defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with > 1-month DAPT outweighs the benefit:

    1. Subjects ≥ 75 years of age.
    2. Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy.
    3. History of major bleeding which required medical attention within 12 months of the index procedure.
    4. History of stroke (ischemic or hemorrhagic).
    5. Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent).
    6. Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count <100,000/mm^3, or any known coagulation disorder associated with increased bleeding risk).
    7. Anemia with hemoglobin < 11g/dl.
  2. Subject must be at least 18 years of age.
  3. Subject must provide written informed consent as approved by the Ethics Committee (EC) of the respective clinical site prior to any trial related procedure.
  4. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol.
  5. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.

Angiographic Inclusion Criteria

  1. Up to three target lesions with a maximum of two target lesions per epicardial vessel.

    Note:

    1. The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the subject must not have >2 lesions requiring treatment within both the LAD and a diagonal branch in total.
    2. If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion.
  2. Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm.
  3. Exclusive use of XIENCE family of stent systems during the index procedure.
  4. Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of <20% with final thrombolysis in myocardial infarction (TIMI-3) flow assessed by online quantitative angiography or visual estimation, with no residual dissection National Heart, Lung, and Blood Institute (NHLBI) grade ≥ type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation > 0.5mm or depression lasting > 5 minutes.

Exclusion Criteria:

  1. Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI).
  2. Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  3. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure.
  4. Subject has a known left ventricular ejection fraction (LVEF) <30%.
  5. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use.
  6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure.
  7. Subject with a current medical condition with a life expectancy of less than 12 months.
  8. Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure.

  9. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

    Note: Female subjects of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release). It is accepted, in certain cases, to include subjects having a sterilised regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the trial design, product characteristics and/or trial population.

  10. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  11. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Angiographic Exclusion Criteria

  1. Target lesion is in a left main location.
  2. Target lesion is located within an arterial or saphenous vein graft.
  3. Target lesion is restenotic from a previous stent implantation.
  4. Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months).
  5. Target lesion is implanted with overlapping stents, whether planned or for bailout.

Note: If there is more than one target lesion, all target lesions must satisfy the angiographic eligibility criteria. Non-target lesion (i.e., lesions that do not meet the angiographic criteria listed above) treatments are not allowed during the index procedure.

Sites / Locations

  • Kepler Universitätsklinikum GmbH
  • Onze-Lieve-Vrouwziekenhuis Campus Aalst
  • UZ Gent
  • Ziekenhuis Oost-Limburg
  • Jesse Ziekenhuis
  • Beijing AnZhen Hospital
  • The Second Hospital of Jilin University
  • Universitäts-Herzzentrum Freiburg - Bad Krozingen
  • Elisabeth-Krankenhaus Essen GmbH
  • UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
  • Herzzentrum Leipzig GmbH
  • Segeberger Kliniken GmbH
  • Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
  • UKE Hamburg (Universitatsklinik Eppendorf)
  • Prince of Wales Hospital
  • Queen Elizabeth Hospital
  • The University of Hong Kong (Queen Mary Hospital)
  • Clinica Mediterranea
  • AOU Federico II - Università degli Studi di Napoli
  • Az.Osp. Universitaria di Ferrara
  • AOU di Parma
  • Policlinico Universitario A. Gemelli
  • Azienda Ospedaliero Universitaria Policlinico Umberto I
  • Centro Cardiologico Monzino
  • Istituto Clinico Humanitas
  • Scheperziekenhuis
  • Medisch Centrum Leeuwarden
  • Albert Schweitzer Ziekenhuis
  • Hospital de Santa Cruz
  • Santa Maria Hospital
  • National Heart Centre Singapore
  • Tan Tock Seng Hospital
  • HCU Virgen de la Victoria
  • Hospital Universitario Marqués de Valdecilla
  • Hospital del Mar
  • Hospital Clinic I Provincial de Barcelona
  • Hospital Clinico Universitario de Valladolid
  • Hospital Alvaro Cunqueiro Dept of Interventional Cardiology
  • Hospital Universitario Doce de Octubre
  • Kantonsspital Aarau
  • Center Inselspital Bern
  • Luzerner Kantonsspital
  • Chang Gung Memorial Hospital
  • Taipei Veterans General Hospital (VGH)
  • National Taiwan University Hospital
  • Kaohsiung Chang Gung Memorial Hospital
  • Freeman Hospital
  • Craigavon Area Hospital
  • Southampton University Hospital
  • Royal Bournemouth Hospital
  • Royal Devon and Exeter Hospital
  • University Hospital of Wales

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XIENCE

Arm Description

XIENCE + Short duration (1 month) of DAPT

Outcomes

Primary Outcome Measures

Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles
Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)

Secondary Outcome Measures

Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the 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 and in the absence of any other obvious cause
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the 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 and in the absence of any other obvious cause
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the 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 and in the absence of any other obvious cause
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients 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 Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients 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 Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients 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 Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
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. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
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. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
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. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Number of Participants With Composite of All Death or All MI (Modified ARC)
All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Number of Participants With Composite of All Death or All MI (Modified ARC)
All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Number of Participants With Composite of All Death or All MI (Modified ARC)
All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Number of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5
Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Number of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5
Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Number of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5
Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.

Full Information

First Posted
November 22, 2017
Last Updated
February 9, 2021
Sponsor
Abbott Medical Devices
search

1. Study Identification

Unique Protocol Identification Number
NCT03355742
Brief Title
XIENCE 28 Global Study
Official Title
XIENCE 28 Global Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 9, 2018 (Actual)
Primary Completion Date
October 24, 2019 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS, XIENCE PROX EECSS, XIENCE ProA EECSS or XIENCE Sierra EECSS of coronary drug-eluting stents
Detailed Description
The XIENCE 28 Global Study will evaluate the safety of 1-month DAPT following XIENCE implantation in HBR patients. A minimum of 800 to a maximum of 960 subjects will be registered from approximately 50 sites globally and subject registration is capped at 120 per site. Eligibility of P2Y12 receptor inhibitor discontinuation will be assessed at 1-month follow-up. Subjects who are free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis (ARC definite/probable) within 1 month (prior to 1-month visit but at least 28 days) after stenting and have been compliant with 1-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days are considered as "1-month clear", and will discontinue P2Y12 receptor inhibitor as early as 28 days and continue with aspirin monotherapy through 12-month follow-up. All registered subjects will be followed at 1, 3, 6 and 12 months post index procedure. The data collected from the XIENCE 28 Global Study will be compared with the historical control of non-complex HBR subjects treated with standard DAPT up to 12 months from the XIENCE V USA Study .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Disorder, Stroke, Ischemic, Stroke Hemorrhagic, Hematological Disease, Thrombocytopenia, Coagulation Disorder, Anemia, Renal Insufficiency, Coronary Artery Disease
Keywords
XIENCE, High bleeding risk (HBR), Dual antiplatelet therapy (DAPT), Coronary Artery Disease, Drug eluting stent (DES)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
963 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XIENCE
Arm Type
Experimental
Arm Description
XIENCE + Short duration (1 month) of DAPT
Intervention Type
Device
Intervention Name(s)
XIENCE
Intervention Description
Subjects who received XIENCE family stent systems will be included.
Intervention Type
Drug
Intervention Name(s)
DAPT
Other Intervention Name(s)
Dual antiplatelet therapy
Intervention Description
1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
Primary Outcome Measure Information:
Title
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE), by Propensity Score Quintiles
Description
Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)
Time Frame
From 1 to 6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Description
Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)
Time Frame
From 6 to 12 months
Title
Number of Participants With Composite of Net Adverse Clinical Endpoint (NACE)
Description
Net Adverse Clinical Endpoint (NACE): A composite rate of all-cause death, all myocardial infarction (modified Academic Research Consortium [ARC]), stent thrombosis (ARC definite or probable), stroke or major bleeding (Bleeding defined by the Bleeding Academic Research Consortium [BARC] type 2-5)
Time Frame
From 1 to 12 months
Title
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Description
Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the 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 and in the absence of any other obvious cause
Time Frame
From 1 to 6 months
Title
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Description
Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the 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 and in the absence of any other obvious cause
Time Frame
From 6 to 12 months
Title
Number of Participants With Stent Thrombosis (ARC Definite/Probable, ARC Definite)
Description
Definite stent thrombosis: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis: Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases: Any unexplained death within the 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 and in the absence of any other obvious cause
Time Frame
From 1 to 12 months
Title
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Description
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients 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
From 1 to 6 months
Title
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Description
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients 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
From 6 to 12 months
Title
Number of Participants With All Death, Cardiac Death, Vascular Death, Non-cardiovascular Death
Description
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients 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
From 1 to 12 months
Title
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Description
Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame
From 1 to 6 months
Title
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Description
Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame
From 6 to 12 months
Title
Number of Participants With All Myocardial Infarction (MI) and MI Attributed to Target Vessel (TV-MI, Modified ARC)
Description
Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame
From 1 to 12 months
Title
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Description
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. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame
From 1 to 6 months
Title
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Description
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. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame
From 6 to 12 months
Title
Number of Participants With Composite of Cardiac Death or MI (Modified ARC)
Description
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. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI: Within 48h after PCI: CK-MB >3 x URL or Troponin > 3 x URL with baseline value < URL Within 72h after CABG: CK-MB >5 x URL or Troponin > 5 x URL with baseline value < URL Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame
From 1 to 12 months
Title
Number of Participants With Composite of All Death or All MI (Modified ARC)
Description
All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame
From 1 to 6 months
Title
Number of Participants With Composite of All Death or All MI (Modified ARC)
Description
All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame
From 6 to 12 months
Title
Number of Participants With Composite of All Death or All MI (Modified ARC)
Description
All death: All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. MI (Modified ARC): Patients present any of the following clinical or imaging evidence of ischemia: Clinical symptoms of ischemia; ECG changes indicative of new ischemia - new ST-T changes or new left bundle branch block (LBBB), development of pathological Q waves; Imaging evidence of a new loss of viable myocardium or a new regional wall motion abnormality) AND confirmed with elevated cardiac biomarkers per ARC criteria: Periprocedural MI Spontaneous MI (> 48h following PCI, > 72h following CABG): CK-MB > URL or Troponin > URL with baseline value < URL
Time Frame
From 1 to 12 months
Title
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Description
An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame
From 1 to 6 months
Title
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Description
An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame
From 6 to 12 months
Title
Number of Participants With All Stroke, Ischemic Stroke and Hemorrhagic Stroke
Description
An acute symptomatic episode of neurological dysfunction attributed to a vascular cause lasting more than 24 hours or lasting 24 hours or less with a brain imaging study or autopsy showing new infarction. Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. Hemorrhagic Stroke: An acute symptomatic episode of focal or global cerebral or spinal dysfunction caused by a non-traumatic intraparenchymal, intraventricular, or subarachnoid hemorrhage. Undetermined Stroke: A stroke with insufficient information to allow categorization as ischemic or hemorrhagic. Pharmacologic, i.e., thrombolytic drug administration, or Non-pharmacologic, i.e., neurointerventional procedure (e.g., intracranial angioplasty)
Time Frame
From 1 to 12 months
Title
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Description
TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame
From 1 to 6 months
Title
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Description
TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame
From 6 to 12 months
Title
Number of Participants With Clinically-indicated Target Lesion Revascularization (CI-TLR)
Description
TLR is defined as any repeat percutaneous intervention of the target lesion (the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent) or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not CI by the investigator prior to repeat angiography. A revascularization is considered CI if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if any one below occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g: Doppler flow velocity reserve, fractional flow reserve); A TLR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame
From 1 to 12 months
Title
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Description
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame
From 1 to 6 months
Title
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Description
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame
From 6 to 12 months
Title
Number of Participants With Clinically-indicated Target Vessel Revascularization (CI-TVR)
Description
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself A revascularization is considered clinically indicated if angiography at follow-up shows a percent diameter stenosis ≥ 50% and if one of the following occurs: A positive history of recurrent angina pectoris, presumably related to the target vessel; Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel; Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve); A TVR with a diameter stenosis ≥70% in the absence of the above mentioned ischemic signs or symptoms.
Time Frame
From 1 to 12 months
Title
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Description
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame
From 1 to 6 months
Title
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Description
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame
From 6 to 12 months
Title
Number of Participants With Target Lesion Failure (TLF, Composite of Cardiac Death, TV-MI and CI-TLR)
Description
TLF is defined as a composite of all cardiac death, myocardial infarction attributed to target vessel or clinically-indicated TLR.
Time Frame
From 1 to 12 months
Title
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Description
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame
From 1 to 6 months
Title
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Description
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame
From 6 to 12 months
Title
Number of Participants With Target Vessel Failure (TVF, a Composite of Cardiac Death, TV-MI and CI-TVR)
Description
TVF is defined as a composite of cardiac death, MI attributed to target vessel, clinically-indicated TLR, or clinically-indicated TVR, non-TLR.
Time Frame
From 1 to 12 months
Title
Number of Participants With Bleeding Defined by the Bleeding Academic Research Consortium (BARC) Type 2-5 and Type 3-5
Description
Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Time Frame
From 1 to 6 months
Title
Number of Participants With Bleeding Defined by the BARC, Type 2-5 and Type 3-5
Description
Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Time Frame
From 6 to 12 months
Title
Number of Participants With Bleeding Defined by BARC, Type 2-5 and Type 3-5
Description
Bleeding per Bleeding Academic Research Consortium (BARC)definitions are as follows: Type 0 Type 1 Type 2 Type 3 Type 4 Type 5 Where, Type 0 indicates no bleeding and type 5 indicates fatal bleeding.
Time Frame
From 1 to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is considered at HBR, defined as meeting one or more of the following criteria at the time of registration and in the opinion of the referring physician, the risk of major bleeding with > 1-month DAPT outweighs the benefit: Subjects ≥ 75 years of age. Clinical indication for chronic (at least 6 months) or lifelong anticoagulation therapy. History of major bleeding which required medical attention within 12 months of the index procedure. History of stroke (ischemic or hemorrhagic). Renal insufficiency (creatinine ≥ 2.0 mg/dl) or failure (dialysis dependent). Systemic conditions associated with an increased bleeding risk (e.g. hematological disorders, including a history of or current thrombocytopenia defined as a platelet count <100,000/mm^3, or any known coagulation disorder associated with increased bleeding risk). Anemia with hemoglobin < 11g/dl. Subject must be at least 18 years of age. Subject must provide written informed consent as approved by the Ethics Committee (EC) of the respective clinical site prior to any trial related procedure. Subject is willing to comply with all protocol requirements, including agreement to stop taking P2Y12 inhibitor at 1 month, if eligible per protocol. Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure. Angiographic Inclusion Criteria Up to three target lesions with a maximum of two target lesions per epicardial vessel. Note: The definition of epicardial vessels means left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX) and right coronary artery (RCA) and their branches. For example, the subject must not have >2 lesions requiring treatment within both the LAD and a diagonal branch in total. If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion. Target lesion must be located in a native coronary artery with visually estimated reference vessel diameter between 2.25 mm and 4.25 mm. Exclusive use of XIENCE family of stent systems during the index procedure. Target lesion has been treated successfully, which is defined as achievement of a final in-stent residual diameter stenosis of <20% with final thrombolysis in myocardial infarction (TIMI-3) flow assessed by online quantitative angiography or visual estimation, with no residual dissection National Heart, Lung, and Blood Institute (NHLBI) grade ≥ type B, and no transient or sustained angiographic complications (e.g., distal embolization, side branch closure), no chest pain lasting > 5 minutes, and no ST segment elevation > 0.5mm or depression lasting > 5 minutes. Exclusion Criteria: Subject with an indication for the index procedure of acute ST-segment elevation MI (STEMI). Subject has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. Subject with implantation of another drug-eluting stent (other than XIENCE) within 12 months prior to index procedure. Subject has a known left ventricular ejection fraction (LVEF) <30%. Subject judged by physician as inappropriate for discontinuation from P2Y12 inhibitor use at 1 month, due to another condition requiring chronic P2Y12 inhibitor use. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor within 1 month following index procedure. Subject with a current medical condition with a life expectancy of less than 12 months. Subject intends to participate in an investigational drug or device trial within 12 months following the index procedure. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test. Note: Female subjects of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release). It is accepted, in certain cases, to include subjects having a sterilised regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the trial design, product characteristics and/or trial population. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. Angiographic Exclusion Criteria Target lesion is in a left main location. Target lesion is located within an arterial or saphenous vein graft. Target lesion is restenotic from a previous stent implantation. Target lesion is a chronic total occlusion (CTO, defined as lesion with TIMI flow 0 for at least 3 months). Target lesion is implanted with overlapping stents, whether planned or for bailout. Note: If there is more than one target lesion, all target lesions must satisfy the angiographic eligibility criteria. Non-target lesion (i.e., lesions that do not meet the angiographic criteria listed above) treatments are not allowed during the index procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Valgimigli, MD
Organizational Affiliation
Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kepler Universitätsklinikum GmbH
City
Linz
State/Province
Upr Aus
ZIP/Postal Code
4021
Country
Austria
Facility Name
Onze-Lieve-Vrouwziekenhuis Campus Aalst
City
Aalst
State/Province
Eflndrs
ZIP/Postal Code
9300
Country
Belgium
Facility Name
UZ Gent
City
Gent
State/Province
Flemish
ZIP/Postal Code
42100
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Jesse Ziekenhuis
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Beijing AnZhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
N China
Country
China
Facility Name
Universitäts-Herzzentrum Freiburg - Bad Krozingen
City
Bad Krozingen
State/Province
Bad-wur
ZIP/Postal Code
79189
Country
Germany
Facility Name
Elisabeth-Krankenhaus Essen GmbH
City
Essen
State/Province
N. Rhin
ZIP/Postal Code
45138
Country
Germany
Facility Name
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
City
Mainz
State/Province
Rhinela
ZIP/Postal Code
55131
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
4289
Country
Germany
Facility Name
Segeberger Kliniken GmbH
City
Bad Segeberg
State/Province
Schlesw
ZIP/Postal Code
23795
Country
Germany
Facility Name
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
UKE Hamburg (Universitatsklinik Eppendorf)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Prince of Wales Hospital
City
Hong Kong
State/Province
Hong Ko
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
State/Province
Hong Ko
Country
Hong Kong
Facility Name
The University of Hong Kong (Queen Mary Hospital)
City
Hong Kong
State/Province
Hong Ko
Country
Hong Kong
Facility Name
Clinica Mediterranea
City
Napoli
State/Province
Campani
ZIP/Postal Code
80122
Country
Italy
Facility Name
AOU Federico II - Università degli Studi di Napoli
City
Napoli
State/Province
Campani
ZIP/Postal Code
80138
Country
Italy
Facility Name
Az.Osp. Universitaria di Ferrara
City
Cona
State/Province
Emi-rom
ZIP/Postal Code
44124
Country
Italy
Facility Name
AOU di Parma
City
Parma
State/Province
Emi-rom
ZIP/Postal Code
43126
Country
Italy
Facility Name
Policlinico Universitario A. Gemelli
City
Roma
State/Province
Latium
ZIP/Postal Code
00168
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Umberto I
City
Rome
State/Province
Latium
ZIP/Postal Code
00161
Country
Italy
Facility Name
Centro Cardiologico Monzino
City
Milano
State/Province
Lombard
ZIP/Postal Code
20138
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Lombard
ZIP/Postal Code
20089
Country
Italy
Facility Name
Scheperziekenhuis
City
Emmen
State/Province
Drenthe
ZIP/Postal Code
7824 AA
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
State/Province
Friesld
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
State/Province
Zuid
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Hospital de Santa Cruz
City
Carnaxide
State/Province
Lisbon
ZIP/Postal Code
2799-523
Country
Portugal
Facility Name
Santa Maria Hospital
City
Lisboa
State/Province
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
National Heart Centre Singapore
City
Singapore
State/Province
Central
ZIP/Postal Code
169609
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
State/Province
Central
ZIP/Postal Code
308433
Country
Singapore
Facility Name
HCU Virgen de la Victoria
City
Malaga
State/Province
Andalu
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabr
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
State/Province
Catalon
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clinic I Provincial de Barcelona
City
Barcelona
State/Province
Catalon
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
State/Province
Cstleon
ZIP/Postal Code
47005
Country
Spain
Facility Name
Hospital Alvaro Cunqueiro Dept of Interventional Cardiology
City
Vigo
State/Province
Pontev
ZIP/Postal Code
36312
Country
Spain
Facility Name
Hospital Universitario Doce de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Kantonsspital Aarau
City
Aarau
State/Province
Basel
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Center Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Luzern
ZIP/Postal Code
6004
Country
Switzerland
Facility Name
Chang Gung Memorial Hospital
City
LinKou
State/Province
Ntaiwan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Taipei Veterans General Hospital (VGH)
City
Taipei City
State/Province
Ntaiwan
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Ntaiwan
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
State/Province
Staiwan
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
State/Province
NE Engl
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Craigavon Area Hospital
City
Portadown
State/Province
Nirelnd
ZIP/Postal Code
BT63 5QQ
Country
United Kingdom
Facility Name
Southampton University Hospital
City
Southampton
State/Province
Soeast
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Sowest
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
Sowest
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34794687
Citation
Valgimigli M, Cao D, Angiolillo DJ, Bangalore S, Bhatt DL, Ge J, Hermiller J, Makkar RR, Neumann FJ, Saito S, Picon H, Toelg R, Maksoud A, Chehab BM, Choi JW, Campo G, De la Torre Hernandez JM, Kunadian V, Sardella G, Thiele H, Varenne O, Vranckx P, Windecker S, Zhou Y, Krucoff MW, Ruster K, Zheng Y, Mehran R; XIENCE 90 and XIENCE 28 Investigators. Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI. J Am Coll Cardiol. 2021 Nov 23;78(21):2060-2072. doi: 10.1016/j.jacc.2021.08.074.
Results Reference
derived
PubMed Identifier
33031789
Citation
Valgimigli M, Cao D, Makkar RR, Bangalore S, Bhatt DL, Angiolillo DJ, Saito S, Ge J, Neumann FJ, Hermiller J, Picon H, Toelg R, Maksoud A, Chehab BM, Wang LJ, Wang J, Mehran R. Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent. Am Heart J. 2021 Jan;231:147-156. doi: 10.1016/j.ahj.2020.09.019. Epub 2020 Oct 6.
Results Reference
derived

Learn more about this trial

XIENCE 28 Global Study

We'll reach out to this number within 24 hrs