Minimum Lumen Diameter (MLD): Pre-procedure
Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.
MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory.
Minimum Lumen Diameter (MLD): Post-procedure
Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.
MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Laboratory.
Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure
Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.
TIMI Classification:
TIMI 0 No perfusion.
TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.
TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.
TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.
Percentage of Participants With Change in TIMI Flow Grade: Post-procedure
Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.
TIMI Classification:
TIMI 0 No perfusion.
TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.
TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.
TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.
Percentage of Participants With Device Success
Achievement of <50% diameter stenosis within the target lesion segment using assigned study device
Percentage of Participants With Procedure Success
Device success and absence of in-hospital MACE.
Per-protocol MI definition: Myocardial infarctions per protocol definition were categorized as Q-wave (development of new, pathological Q waves on the ECG) or non-Q-wave (elevation of CK levels to greater than two times the upper limit of normal and elevated CK-MB in the absence of new pathological Q waves).
Per ARC MI definition: Myocardial infarctions per ARC definition were also categorized as Q-wave (development of new pathological Q waves in 2 or more contiguous leads (according to the Minnesota code) with or without post-procedure CK or CK-MB levels elevated above normal) or non-Q-wave (all MIs not classified as Q-wave). ARC defined MIs were further classified as Periprocedural PCI, Periprocedural CABG, Spontaneous, Sudden Death, and Reinfarction based on biomarker and additional criteria and as ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) based on ST segment.
Percentage of Participants With Procedural Success With Antegrade Crossing
Defined as device success and absence of in-hospital MACE with antegrade crossing technique.
Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Percentage of Participants With Procedural Success With Knuckle Wire
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART)
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Percentage of Participants With Procedural Success With Reverse CART
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Percentage of Participants With Procedural Success With Kissing Wire Technique
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Percentage of Participants With Procedural Success With Sub Intimal Technique
Defined as device success and absence of in-hospital MACE with antegrade crossing technique.
Percentage of Participants With Procedural Success With Multiple Crossing Techniques
Defined as device success and absence of in-hospital MACE with antegrade crossing technique
Resource Utilization: Procedural Time
Resource Utilization: Fluoroscopic Time
Resource Utilization: Contrast Volume
Percentage of Participants With Clinically Significant Perforation
Any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft or comparable therapy
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Number of Participants With Major Adverse Cardiac Events (MACE)
Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.
Number of Participants Experiencing Death
MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants Experiencing Death
MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants Experiencing Death
MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants Experiencing Death
MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants Experiencing Death
MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants Experiencing Death
MACE Component; per protocol.
Death is divided into 2 categories:
Cardiac death is defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.
Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants Experiencing Cardiac Death
TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded
Number of Participants Experiencing Cardiac Death
TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded
Number of Participants Experiencing Cardiac Death
TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded
Number of Participants Experiencing Cardiac Death
TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded
Number of Participants Experiencing Cardiac Death
TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded
Number of Participants Experiencing Cardiac Death
TLF component.
Cardiac death was defined as death due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component;
Myocardial Infarction (per ARC definition)
Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
Non-Q-wave MI: All MIs not classified as Q-wave.
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component;
Myocardial Infarction (per ARC definition)
Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
Non-Q-wave MI: All MIs not classified as Q-wave.
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component;
Myocardial Infarction (per ARC definition)
Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
Non-Q-wave MI: All MIs not classified as Q-wave.
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component;
Myocardial Infarction (per ARC definition)
Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
Non-Q-wave MI: All MIs not classified as Q-wave.
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component;
Myocardial Infarction (per ARC definition)
Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
Non-Q-wave MI: All MIs not classified as Q-wave.
Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)
MACE Component;
Myocardial Infarction (per ARC definition)
Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
Non-Q-wave MI: All MIs not classified as Q-wave.
Number of Participants With Target Vessel-related MI
TLF Component; per ARC
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Number of Participants With Target Vessel-related MI
TLF Component; per ARC
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Number of Participants With Target Vessel-related MI
TLF Component; per ARC
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Number of Participants With Target Vessel-related MI
TLF Component; per ARC
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Number of Participants With Target Vessel-related MI
TLF Component; per ARC
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Number of Participants With Target Vessel-related MI
TLF Component; per ARC
Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.
Number of Participants With Target Lesion Revascularization (TLR)
Repeat percutaneous coronary intervention (PCI) or Coronary artery bypass graft (CABG) to the target lesion/site.
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Number of Participants With Target Lesion Revascularization (TLR)
Repeat PCI or CABG to the target lesion/site.
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.
Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.
Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)
TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel.
Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel.
Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel.
Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel.
Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study
Number of Participants With All Target Vessel Revascularization (TVR)
Repeat PCI or CABG of the target vessel.
Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when any of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined.
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined.
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined.
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined.
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined.
Number of Participants With Target Vessel Failure (TVF)
Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.
Target vessel failure will be reported when ANY of the following events occur:
Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined.
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR
Number of Participants With Target Lesion Failure (TLF)
Composite of cardiac death, target vessel-related MI, and clinically-driven TLR
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria; definite and probable
Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria; definite and probable.
Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria; definite and probable.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Number of Participants With Stent Thrombosis
Academic Research Consortium (ARC) criteria.
Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).
Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.
Number of Participants With Occurrence of Stent Fracture at Target Lesion
Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.
Number of Participants With Occurrence of Stent Fracture at Target Lesion
Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.
Number of Participants With Occurrence of Stent Fracture at Target Lesion
Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.
Number of Participants With Occurrence of Stent Fracture at Target Lesion
Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.