EXCEL Clinical Trial (EXCEL)

Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization.

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

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Disease; Stent Thrombosis; Coronary Restenosis; Chronic Coronary Occlusion; Vascular Disease; Coronary Artery Stenosis; Unprotected Left Main Coronary Artery Disease
• Intervention / Treatment: Device: Percutaneous Coronary Intervention; Procedure: CABG

• Study Type: Interventional
• Enrollment (Actual): 1905
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Clara, California, United States, 95054
      • Abbott Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

* Inclusion criteria for RCT:

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

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

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

Exclusion Criteria:

* Clinical exclusion criteria:

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

Angiographic exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous Coronary Intervention; Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS	Device: Percutaneous Coronary Intervention; Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
Active Comparator: Coronary Artery Bypass Graft; Those patients receiving CABG	Procedure: CABG; Those patients receiving CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke	All deaths includes Cardiac death, Vascular death and Non-cardiovascular death. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG.; Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Gregg W Stone, MD, Columbia University; Principal Investigator: Patrick W Serruys, MD, Erasmus Medical Center; Principal Investigator: Joseph Sabik, MD, Cleveland Clinical Main Campus; Principal Investigator: A. Pieter Kappetein, MD, Erasmus Medical Center

Publications and helpful links

General Publications

• Magnuson EA, Chinnakondepalli K, Vilain K, Serruys PW, Sabik JF, Kappetein AP, Stone GW, Cohen DJ; EXCEL Investigators. Cost-Effectiveness of Percutaneous Coronary Intervention Versus Bypass Surgery for Patients With Left Main Disease: Results From the EXCEL Trial. Circ Cardiovasc Interv. 2022 Jul;15(7):e011981. doi: 10.1161/CIRCINTERVENTIONS.122.011981. Epub 2022 Jul 19.
• Myat A, Hildick-Smith D, de Belder AJ, Trivedi U, Crowley A, Morice MC, Kandzari DE, Lembo NJ, Brown WM III, Serruys PW, Kappetein AP, Sabik JF III, Stone G. Geographical variations in left main coronary artery revascularisation: a prespecified analysis of the EXCEL trial. EuroIntervention. 2022 Jan 28;17(13):1081-1090. doi: 10.4244/EIJ-D-21-00338.
• Gregson J, Stone GW, Ben-Yehuda O, Redfors B, Kandzari DE, Morice MC, Leon MB, Kosmidou I, Lembo NJ, Brown WM 3rd, Karmpaliotis D, Banning AP, Pomar J, Sabate M, Simonton CA, Dressler O, Kappetein AP, Sabik JF 3rd, Serruys PW, Pocock SJ. Implications of Alternative Definitions of Peri-Procedural Myocardial Infarction After Coronary Revascularization. J Am Coll Cardiol. 2020 Oct 6;76(14):1609-1621. doi: 10.1016/j.jacc.2020.08.016.
• Gaba P, Serruys PW, Sabik JF 3rd, Kappetein AP, Chen S, Morice MC, Kandzari DE, Crowley A, Mehran R, Stone GW. Effect of Baseline Anemia on Outcomes After Left Main Coronary Revascularization. J Am Coll Cardiol. 2020 Mar 31;75(12):1493-1495. doi: 10.1016/j.jacc.2020.01.037. No abstract available.
• Thuijs DJFM, Milojevic M, Stone GW, Puskas JD, Serruys PW, Sabik JF 3rd, Dressler O, Crowley A, Head SJ, Kappetein AP. Impact of left ventricular ejection fraction on clinical outcomes after left main coronary artery revascularization: results from the randomized EXCEL trial. Eur J Heart Fail. 2020 May;22(5):871-879. doi: 10.1002/ejhf.1681. Epub 2020 Feb 11.
• Giustino G, Serruys PW, Sabik JF 3rd, Mehran R, Maehara A, Puskas JD, Simonton CA, Lembo NJ, Kandzari DE, Morice MC, Taggart DP, Gershlick AH, Ragosta M 3rd, Kron IL, Liu Y, Zhang Z, McAndrew T, Dressler O, Genereux P, Ben-Yehuda O, Pocock SJ, Kappetein AP, Stone GW. Mortality After Repeat Revascularization Following PCI or CABG for Left Main Disease: The EXCEL Trial. JACC Cardiovasc Interv. 2020 Feb 10;13(3):375-387. doi: 10.1016/j.jcin.2019.09.019. Epub 2020 Jan 15.
• Kandzari DE, Gershlick AH, Serruys PW, Leon MB, Morice MC, Simonton CA, Lembo NJ, Mansour S, Sabate M, Sabik JF 3rd, Kappetein AP, Dressler O, Stone GW. Procedural characteristics and clinical outcomes in patients undergoing percutaneous coronary intervention for left main trifurcation disease: the EXCEL trial. EuroIntervention. 2020 Dec 18;16(12):e982-e988. doi: 10.4244/EIJ-D-19-00686.
• Stone GW, Kappetein AP, Sabik JF, Pocock SJ, Morice MC, Puskas J, Kandzari DE, Karmpaliotis D, Brown WM 3rd, Lembo NJ, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman PE, Bochenek A, Schampaert E, Page P, Modolo R, Gregson J, Simonton CA, Mehran R, Kosmidou I, Genereux P, Crowley A, Dressler O, Serruys PW; EXCEL Trial Investigators. Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease. N Engl J Med. 2019 Nov 7;381(19):1820-1830. doi: 10.1056/NEJMoa1909406. Epub 2019 Sep 28. Erratum In: N Engl J Med. 2020 Mar 12;382(11):1078.
• Shlofmitz E, Genereux P, Chen S, Dressler O, Ben-Yehuda O, Morice MC, Puskas JD, Taggart DP, Kandzari DE, Crowley A, Redfors B, Mehdipoor G, Kappetein AP, Sabik JF 3rd, Serruys PW, Stone GW. Left Main Coronary Artery Disease Revascularization According to the SYNTAX Score. Circ Cardiovasc Interv. 2019 Sep;12(9):e008007. doi: 10.1161/CIRCINTERVENTIONS.118.008007. Epub 2019 Sep 9.
• Thuijs DJFM, Habib RH, Head SJ, Puskas JD, Taggart DP, Stone GW, Zhang Z, Serruys PW, Sabik JF 3rd, Kappetein AP. Prognostic performance of the Society of Thoracic Surgeons risk score in patients with left main coronary artery disease undergoing revascularisation: a post hoc analysis of the EXCEL trial. EuroIntervention. 2020 May 20;16(1):36-43. doi: 10.4244/EIJ-D-19-00417.
• Modolo R, Chichareon P, Kogame N, Dressler O, Crowley A, Ben-Yehuda O, Puskas J, Banning A, Taggart DP, Kappetein AP, Sabik JA, Onuma Y, Stone GW, Serruys PW. Contemporary Outcomes Following Coronary Artery Bypass Graft Surgery for Left Main Disease. J Am Coll Cardiol. 2019 Apr 23;73(15):1877-1886. doi: 10.1016/j.jacc.2018.12.090.
• Milojevic M, Serruys PW, Sabik JF 3rd, Kandzari DE, Schampaert E, van Boven AJ, Horkay F, Ungi I, Mansour S, Banning AP, Taggart DP, Sabate M, Gershlick AH, Bochenek A, Pomar J, Lembo NJ, Noiseux N, Puskas JD, Crowley A, Kosmidou I, Mehran R, Ben-Yehuda O, Genereux P, Pocock SJ, Simonton CA, Stone GW, Kappetein AP. Bypass Surgery or Stenting for Left Main Coronary Artery Disease in Patients With Diabetes. J Am Coll Cardiol. 2019 Apr 9;73(13):1616-1628. doi: 10.1016/j.jacc.2019.01.037.
• Huang X, Redfors B, Chen S, Liu Y, Ben-Yehuda O, Puskas JD, Kandzari DE, Merkely B, Horkay F, van Boven AJ, Boonstra PW, Sabik JF, Serruys PW, Kappetein AP, Stone GW. Impact of chronic obstructive pulmonary disease on prognosis after percutaneous coronary intervention and bypass surgery for left main coronary artery disease: an analysis from the EXCEL trial. Eur J Cardiothorac Surg. 2019 Jun 1;55(6):1144-1151. doi: 10.1093/ejcts/ezy438.
• Kandzari DE, Gershlick AH, Serruys PW, Leon MB, Morice MC, Simonton CA, Lembo NJ, Banning AP, Merkely B, van Boven AJ, Ungi I, Kappetein AP, Sabik JF 3rd, Genereux P, Dressler O, Stone GW. Outcomes Among Patients Undergoing Distal Left Main Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2018 Oct;11(10):e007007. doi: 10.1161/CIRCINTERVENTIONS.118.007007.
• Giustino G, Mehran R, Serruys PW, Sabik JF 3rd, Milojevic M, Simonton CA, Puskas JD, Kandzari DE, Morice MC, Taggart DP, Gershlick AH, Genereux P, Zhang Z, McAndrew T, Redfors B, Ragosta M 3rd, Kron IL, Dressler O, Leon MB, Pocock SJ, Ben-Yehuda O, Kappetein AP, Stone GW. Left Main Revascularization With PCI or CABG in Patients With Chronic Kidney Disease: EXCEL Trial. J Am Coll Cardiol. 2018 Aug 14;72(7):754-765. doi: 10.1016/j.jacc.2018.05.057.
• Redfors B, Chen S, Crowley A, Ben-Yehuda O, Gersh BJ, Lembo NJ, Brown WM 3rd, Banning AP, Taggart DP, Serruys PW, Kappetein AP, Sabik JF 3rd, Stone GW. B-Type Natriuretic Peptide Assessment in Patients Undergoing Revascularization for Left Main Coronary Artery Disease: Analysis From the EXCEL Trial. Circulation. 2018 Jul 31;138(5):469-478. doi: 10.1161/CIRCULATIONAHA.118.033631.
• Kosmidou I, Chen S, Kappetein AP, Serruys PW, Gersh BJ, Puskas JD, Kandzari DE, Taggart DP, Morice MC, Buszman PE, Bochenek A, Schampaert E, Page P, Sabik JF 3rd, McAndrew T, Redfors B, Ben-Yehuda O, Stone GW. New-Onset Atrial Fibrillation After PCI or CABG for Left Main Disease: The EXCEL Trial. J Am Coll Cardiol. 2018 Feb 20;71(7):739-748. doi: 10.1016/j.jacc.2017.12.012.
• Baron SJ, Chinnakondepalli K, Magnuson EA, Kandzari DE, Puskas JD, Ben-Yehuda O, van Es GA, Taggart DP, Morice MC, Lembo NJ, Brown WM 3rd, Banning A, Simonton CA, Kappetein AP, Sabik JF, Serruys PW, Stone GW, Cohen DJ; EXCEL Investigators. Quality-of-Life After Everolimus-Eluting Stents or Bypass Surgery for Left-Main Disease: Results From the EXCEL Trial. J Am Coll Cardiol. 2017 Dec 26;70(25):3113-3122. doi: 10.1016/j.jacc.2017.10.036. Epub 2017 Oct 30.
• Stone GW, Sabik JF, Serruys PW, Simonton CA, Genereux P, Puskas J, Kandzari DE, Morice MC, Lembo N, Brown WM 3rd, Taggart DP, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman P, Bochenek A, Schampaert E, Page P, Dressler O, Kosmidou I, Mehran R, Pocock SJ, Kappetein AP; EXCEL Trial Investigators. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease. N Engl J Med. 2016 Dec 8;375(23):2223-2235. doi: 10.1056/NEJMoa1610227. Epub 2016 Oct 31. Erratum In: N Engl J Med. 2019 Oct 31;381(18):1789.
• Farooq V, Serruys PW. Bypass Grafting Versus Percutaneous Intervention-Which Is Better in Multivessel Coronary Disease: Lessons From SYNTAX and Beyond. Prog Cardiovasc Dis. 2015 Nov-Dec;58(3):316-34. doi: 10.1016/j.pcad.2015.10.002. Epub 2015 Oct 31.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2010
• Primary Completion (Actual): May 3, 2019
• Study Completion (Actual): June 28, 2019

Study Registration Dates

• First Submitted: September 16, 2010
• First Submitted That Met QC Criteria: September 17, 2010
• First Posted (Estimate): September 20, 2010

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Stents; Drug eluting stents; Coronary artery bypass graft surgery; Unprotected Left Main Coronary Artery Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases; Ischemia; Thrombosis; Coronary Occlusion; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: 10-389