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EXCEL Clinical Trial (EXCEL)

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ClinicalTrials.gov Identifier: NCT01205776
Recruitment Status : Active, not recruiting
First Posted : September 20, 2010
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

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

Condition or disease Intervention/treatment Phase
Chronic Coronary Occlusion Unprotected Left Main Coronary Artery Disease Stent Thrombosis Vascular Disease Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis Device: Percutaneous Coronary Intervention Procedure: CABG Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1905 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization.
Study Start Date : September 2010
Actual Primary Completion Date : April 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [ Time Frame: 3 years ]

    All deaths includes Cardiac death, Vascular death and Non-cardiovascular death.

    Myocardial Infarction (MI):

    • Q wave MI: Development of new, pathological Q wave on the ECG.
    • Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.

    Stroke is defined as the rapid onset of a new persistent neurologic deficit attributed to an obstruction in cerebral blood flow and/or cerebral hemorrhage with no apparent non-vascular cause (e.g., trauma, tumor, or infection).



Secondary Outcome Measures :
  1. Numberof Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [ Time Frame: 30 days ]

    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).


  2. Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [ Time Frame: 3 years ]

    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.


  3. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]

    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).


  4. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [ Time Frame: 0 to 6 months ]

    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. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [ Time Frame: 0 to 1 year ]

    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).


  6. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [ Time Frame: 0 to 2 years ]

    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).


  7. Number of Participants With All-cause Death, Protocol Defined MI or Protocol Defined Stroke [ Time Frame: 0 to 3 years ]

    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).


  8. Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]

    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).


  9. Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [ Time Frame: 0-30 days ]

    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).


  10. Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [ Time Frame: 0 to 6 months ]

    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).


  11. Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [ Time Frame: 0 to 1 year ]

    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).


  12. Number of Participants Experienced Death, Protocol Defined MI, Protocol Defined Stroke or Unplanned Revascularization for Ischemia [ Time Frame: 0 to 2 years ]

    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).


  13. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]

    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.


  14. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [ Time Frame: 0-30 days ]

    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.


  15. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [ Time Frame: 0 to 1 year ]

    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.


  16. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [ Time Frame: 0 to 6 months ]

    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.


  17. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [ Time Frame: 0 to 2 years ]

    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.


  18. Number of Participants With All-cause Mortality (Cardiac Death and Non-cardiac Death) [ Time Frame: 0 to 3 years ]

    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.


  19. Number of Participants With Protocol Defined MI [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]

    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.


  20. Number of Participants With Protocol Defined MI [ Time Frame: 0-30 days ]

    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.


  21. Number of Participants With Protocol Defined MI [ Time Frame: 0 to 6 months ]

    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.


  22. Number of Participants With Protocol Defined MI [ Time Frame: 0 to 1 year ]

    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.


  23. Number of Participants With Protocol Defined MI [ Time Frame: 0 to 2 years ]

    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.


  24. Number of Participants With Protocol Defined MI [ Time Frame: 0 to 3 years ]

    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.


  25. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]

    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.

  26. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [ Time Frame: 0-30 days ]

    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.

  27. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [ Time Frame: 0 to 6 months ]

    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.

  28. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [ Time Frame: 0 to 1 year ]

    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.

  29. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [ Time Frame: 0 to 2 years ]

    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.

  30. Number of Participants With All Stroke (Ischemic Stroke, and Hemorrhagic Stroke) [ Time Frame: 0 to 3 years ]

    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.

  31. Number of Participants With Disability Following Stroke Event [ Time Frame: 90 days ± 2 weeks ]

    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.


  32. Number of Participants With Ischemia Driven Revascularizations (TLR,TVR and Non-TVR) [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]

    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

  33. Number of Participants With Ischemia Driven Revascularizations [ Time Frame: 0-30 days ]

    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

  34. Number of Participants With Ischemia Driven Revascularizations [ Time Frame: 0 to 6 months ]

    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

  35. Number of Participants With Ischemia Driven Revascularizations [ Time Frame: 0 to 1 year ]

    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

  36. Number of Participants With Ischemia Driven Revascularizations [ Time Frame: 0 to 2 years ]

    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

  37. Number of Participants With Ischemia Driven Revascularizations [ Time Frame: 0 to 3 years ]

    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

  38. Number of Participants With All Revascularizations (Ischemia-driven or Non Ischemia-driven) [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]
    • A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:

      • A positive functional study corresponding to the area served by the target lesion;
      • Ischemic ECG changes at rest in a distribution consistent with the target vessel;
      • Typical ischemic symptoms referable to the target lesion;
      • IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the
      • plaque burden must also be ≥ 60%;
      • FFR of the target lesion ≤ 0.80
    • A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

  39. Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) [ Time Frame: 0-30 days ]
    • A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:

      • A positive functional study corresponding to the area served by the target lesion;
      • Ischemic ECG changes at rest in a distribution consistent with the target vessel;
      • Typical ischemic symptoms referable to the target lesion;
      • IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the
      • plaque burden must also be ≥ 60%;
      • FFR of the target lesion ≤ 0.80
    • A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

  40. Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) [ Time Frame: 0 to 6 months ]
    • A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:

      • A positive functional study corresponding to the area served by the target lesion;
      • Ischemic ECG changes at rest in a distribution consistent with the target vessel;
      • Typical ischemic symptoms referable to the target lesion;
      • IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the
      • plaque burden must also be ≥ 60%;
      • FFR of the target lesion ≤ 0.80
    • A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

  41. Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) [ Time Frame: 0 to 1 year ]
    • A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:

      • A positive functional study corresponding to the area served by the target lesion;
      • Ischemic ECG changes at rest in a distribution consistent with the target vessel;
      • Typical ischemic symptoms referable to the target lesion;
      • IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the
      • plaque burden must also be ≥ 60%;
      • FFR of the target lesion ≤ 0.80
    • A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

  42. Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) [ Time Frame: 0 to 2 years ]
    • A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:

      • A positive functional study corresponding to the area served by the target lesion;
      • Ischemic ECG changes at rest in a distribution consistent with the target vessel;
      • Typical ischemic symptoms referable to the target lesion;
      • IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the
      • plaque burden must also be ≥ 60%;
      • FFR of the target lesion ≤ 0.80
    • A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

  43. Number of Participants With All Revascularizations (Ischemia Driven and Not Ischemia Driven) [ Time Frame: 0 to 3 years ]
    • A target lesion (vessel) revascularization will be considered ischemia-driven if the target lesion diameter stenosis is ≥ 50% by QCA (analysis segment measurement, involving the lesion itself and 5 mm of proximal and/or distal margin) and any of the following criteria for ischemia are met:

      • A positive functional study corresponding to the area served by the target lesion;
      • Ischemic ECG changes at rest in a distribution consistent with the target vessel;
      • Typical ischemic symptoms referable to the target lesion;
      • IVUS of the target lesion with a minimal lumen area (MLA) of ≤ 4 mm^2 for non left main lesions or ≤ 6 mm^2 for left main lesions. If the lesions are de novo (i.e. not restenotic), the
      • plaque burden must also be ≥ 60%;
      • FFR of the target lesion ≤ 0.80
    • A non target vessel revascularization will be considered ischemia-driven if any lesion the non target vessel has a diameter stenosis ≥ 50% by QCA with any of the above criteria for ischemia met.

  44. Percentage of Participants With Major Adverse Events (MAE) [ Time Frame: in-hospital ]
    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.

  45. Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable [ Time Frame: Acute (<= 24 hours) ]

    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.

  46. Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable [ Time Frame: Subacute (1-30 days) ]

    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.

  47. Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable [ Time Frame: Early (0-30 days) ]

    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.

  48. Number of Participants With Stent Thrombosis (ARC Definition) Definite/Probable [ Time Frame: Late (>30 days - 1 year) ]

    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.

  49. Number of Participants With Stent Thrombosis (ARC Definition) Definite/ Probable [ Time Frame: Very late (>1 year) ]

    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.

  50. Number of Participants With Graft Stenosis or Occlusion [ Time Frame: in-hospital (≤ 7 days of index-procedure) ]
    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

  51. Number of Participants With Graft Stenosis or Occlusion [ Time Frame: 0-30 days ]
    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

  52. Number of Participants With Graft Stenosis or Occlusion [ Time Frame: 0 to 6 months ]
    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

  53. Number of Participants With Graft Stenosis or Occlusion [ Time Frame: 0 to 1 year ]
    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

  54. Number of Participants With Graft Stenosis or Occlusion [ Time Frame: 0 to 2 years ]
    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

  55. Number of Participants With Graft Stenosis or Occlusion [ Time Frame: 0 to 3 years ]
    Graft stenosis or occlusion is defined as Ischemic symptoms in the presence of ≥50% diameter stenosis in a coronary bypass graft.

  56. Number of Participants With Requirement for Blood Product Transfusion [ Time Frame: 30 days ]

    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].

  57. Number of Participants With Requirement for Blood Product Transfusion [ Time Frame: 3 years ]

    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].

  58. Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding [ Time Frame: 30 days ]

    Bleeding will be classified by the TIMI hemorrhage classification

    Severity:

    Major:

    • Intracranial hemorrhage
    • A ≥5 g/dL decrease in the hemoglobin concentration
    • A ≥15% absolute decrease in the hematocrit

    Minor:

    • Observed blood loss:

      • A ≥ 3 g/dL decrease in the hemoglobin concentration
      • A ≥ 10% absolute decrease in the hematocrit
    • No observed blood loss:

      • A ≥ 4 g/dL decrease in the hemoglobin concentration
      • A ≥ 12% absolute decrease in the hematocrit

    Minimal:

    • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.


  59. Number of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding [ Time Frame: 3 years ]

    Bleeding will be classified by the TIMI hemorrhage classification

    Severity:

    Major:

    • Intracranial hemorrhage
    • A ≥5 g/dL decrease in the hemoglobin concentration
    • A ≥15% absolute decrease in the hematocrit

    Minor:

    • Observed blood loss:

      • A ≥ 3 g/dL decrease in the hemoglobin concentration
      • A ≥ 10% absolute decrease in the hematocrit
    • No observed blood loss:

      • A ≥ 4 g/dL decrease in the hemoglobin concentration
      • A ≥ 12% absolute decrease in the hematocrit

    Minimal:

    • Any clinically overt sign of hemorrhage (including imaging) that is associated with a < 3 g/dL decrease in hemoglobin concentration or < 9% decrease in the hematocrit.


  60. Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding [ Time Frame: 30 days ]

    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

  61. Number of Participants With Bleeding Academic Research Consortium (BARC) Bleeding [ Time Frame: 3 years ]

    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

  62. Number of Participants With Major Adverse Events (MAE) [ Time Frame: 30 days ]
    • 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

  63. Number of Participants With Complete Revascularization (Residual = 0) [ Time Frame: At Baseline ]
    1. 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.)

    2. 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.
    3. 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).
    4. Following CABG, the angiographic core lab will determine the extent of revascularization or if there is a repeat angiogram during the index hospitalization.

  64. Number of Participants With Definite Stent Thrombosis (ST) or Symptomatic Graft Occlusion [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]

    - 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.


  65. Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion [ Time Frame: 1 year ]

    - 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.


  66. Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion [ Time Frame: 2 years ]

    - 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.


  67. Number of Participants With Definite Stent Thrombosis or Symptomatic Graft Occlusion [ Time Frame: 3 years ]

    - 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

* Inclusion criteria for RCT:

  • Unprotected left main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) ≥70% requiring revascularization, or
  • ULMCA disease with agniographic DS >=50% but < 70% requiring revascularization, with one or more of the following present:

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

Exclusion Criteria:

* Clinical exclusion criteria:

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

Angiographic exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205776


Locations
United States, California
Abbott Vascular
Santa Clara, California, United States, 95054
Sponsors and Collaborators
Abbott Vascular
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
  Study Documents (Full-Text)

Documents provided by Abbott Vascular:
Study Protocol  [PDF] February 8, 2016
Statistical Analysis Plan  [PDF] January 26, 2016


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01205776     History of Changes
Other Study ID Numbers: 10-389
First Posted: September 20, 2010    Key Record Dates
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018
Last Verified: February 2018

Keywords provided by Abbott Vascular:
Drug eluting stents
Stents
Unprotected Left Main Coronary Artery Disease
Coronary artery bypass graft surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Thrombosis
Vascular Diseases
Coronary Stenosis
Coronary Restenosis
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Embolism and Thrombosis