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ABSORB II Randomized Controlled Trial (ABSORB II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01425281
Recruitment Status : Completed
First Posted : August 30, 2011
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE)

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System Device: Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System Not Applicable

Detailed Description:
In the USA, ABSORB BVS is currently in development at Abbott Vascular. Not available for sale in the US.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: ABSORB II RANDOMIZED CONTROLLED TRIAL A Clinical Evaluation to Compare the Safety, Efficacy and Performance of ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System Against XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by de Novo Native Coronary Artery Lesions
Study Start Date : November 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : May 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: XIENCE™
Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System
Device: Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System
XIENCE implantation in the treatment of coronary artery disease.

Experimental: ABSORB BVS™
Experimental: Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
Device: Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
ABSORB BVS implantation in the treatment of coronary artery disease.




Primary Outcome Measures :
  1. Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD) [ Time Frame: 3 years ]
    In-scaffold:Within the margins of the scaffold.

  2. Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter [ Time Frame: 3 years ]
    In-scaffold:Within the margins of the scaffold.


Secondary Outcome Measures :
  1. Device Success [ Time Frame: From the start of index procedure to end of index procedure ]
    Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).

  2. Number of Participants With Procedural Success [ Time Frame: From the start of index procedure to end of index procedure ]
    Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay.

  3. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) [ Time Frame: In-hospital (≤ 7 days of post 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.

  4. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) [ Time Frame: 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.


  5. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) [ Time Frame: 180 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.


  6. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) [ Time Frame: 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.


  7. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) [ Time Frame: 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.


  8. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) [ Time Frame: 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.


  9. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) [ Time Frame: 4 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.

  10. Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular) [ Time Frame: 5 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.

  11. Number of Participants With All Myocardial Infarction (Per Protocol Definition) [ 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 Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated Creatine kinase-MB (CK-MB) in the absence of new pathological Q waves.


  12. Number of Participants With All Myocardial Infarction (Per Protocol Definition) [ Time Frame: 30 days ]

    Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.

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


  13. Number of Participants With All Myocardial Infarction (Per Protocol Definition) [ Time Frame: 180 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.


  14. Number of Participants With All Myocardial Infarction (Per Protocol Definition) [ Time Frame: 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.


  15. Number of Participants With All Myocardial Infarction (Per Protocol Definition) [ Time Frame: 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.


  16. Number of Participants With All Myocardial Infarction (Per Protocol Definition) [ Time Frame: 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.


  17. Number of Participants With All Myocardial Infarction (Per Protocol Definition) [ Time Frame: 4 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.

  18. Number of Participants With All Myocardial Infarction (Per Protocol Definition) [ Time Frame: 5 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.

  19. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  20. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 30 days ]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  21. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 180 days ]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  22. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 1 year ]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  23. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 2 years ]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  24. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 3 years ]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  25. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 4 years ]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  26. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 5 years ]

    Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.

    The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.


  27. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  28. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 30 days ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  29. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 180 days ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  30. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 1 year ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  31. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 2 years ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  32. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 3 years ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  33. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 4 years ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  34. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 5 years ]
    Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

  35. Number of Participants With Non Target Vessel Revascularization (Non-TVR) [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]
    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  36. Number of Participants With Non Target Vessel Revascularization (Non-TVR) [ Time Frame: 30 days ]
    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  37. Number of Participants With Non Target Vessel Revascularization (Non-TVR) [ Time Frame: 180 days ]
    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  38. Number of Participants With Non Target Vessel Revascularization (Non-TVR) [ Time Frame: 1 year ]
    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  39. Number of Participants With Non Target Vessel Revascularization (Non-TVR) [ Time Frame: 2 years ]
    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  40. Number of Participants With Non Target Vessel Revascularization (Non-TVR) [ Time Frame: 3 years ]
    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  41. Number of Participants With Non Target Vessel Revascularization (Non-TVR) [ Time Frame: 4 years ]
    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  42. Number of Participants With Non-Target Vessel Revascularization (Non-TVR) [ Time Frame: 5 years ]
    Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.

  43. Number of Participants With All Revascularization [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]

    Revascularization:

    Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.

    Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.

    Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.

    Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.


  44. Number of Participants With All Revascularization [ Time Frame: 30 days ]

    Revascularization:

    • Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
    • Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
    • Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
    • Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  45. Number of Participants With All Revascularization [ Time Frame: 180 days ]

    Revascularization:

    • Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
    • Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
    • Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
    • Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  46. Number of Participants With All Revascularization [ Time Frame: 1 year ]

    Revascularization:

    • Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
    • Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
    • Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
    • Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  47. Number of Participants With All Revascularization [ Time Frame: 2 years ]

    Revascularization:

    • Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
    • Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
    • Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
    • Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  48. Number of Participants With All Revascularization [ Time Frame: 3 years ]

    Revascularization:

    • Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
    • Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
    • Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
    • Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  49. Number of Participants With All Revascularization [ Time Frame: 4 years ]

    Revascularization:

    • Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.
    • Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.
    • Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.
    • Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  50. Number of Participants With All Revascularization [ Time Frame: 5 years ]
    Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.

  51. Number of Participants Experiencing All Death/All MI [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]

    All deaths includes

    • 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.

    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.


  52. Number of Participants Experiencing All Death/All MI [ Time Frame: 30 days ]

    All deaths includes

    • 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.

    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.

  53. Number of Participants Experiencing All Death/All MI [ Time Frame: 180 days ]

    All deaths includes

    • 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.

    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.

  54. Number of Participants Experiencing All Death/All MI [ Time Frame: 1 year ]

    All deaths includes

    • 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.

    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.

  55. Number of Participants Experiencing All Death/All MI [ Time Frame: 2 years ]

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed 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.

    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.

  56. Number of Participants Experiencing All Death/All MI [ Time Frame: 3 years ]

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed 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.

    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.

  57. Number of Participants Experiencing All Death/All MI [ Time Frame: 4 years ]

    All deaths includes

    • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed 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. 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.

  58. Number of Participants Experiencing All Death/All MI [ Time Frame: 5 years ]

    All deaths includes

    • 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. 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.

  59. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death,(Target Vessel Myocardial Infarction(TV-MI), ID-TLR) [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  60. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, Target Vessel Myocardial Infarction (TV-MI), ID-TLR) [ Time Frame: 30 days ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  61. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) [ Time Frame: 180 days ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  62. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) [ Time Frame: 1 year ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  63. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) [ Time Frame: 2 years ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  64. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) [ Time Frame: 3 years ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  65. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) [ Time Frame: 4 years ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  66. Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR) [ Time Frame: 5 years ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  67. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  68. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) [ Time Frame: 30 days ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  69. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) [ Time Frame: 180 days ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  70. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) [ Time Frame: 1 year ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  71. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) [ Time Frame: 2 years ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  72. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) [ Time Frame: 3 years ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  73. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) [ Time Frame: 4 years ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  74. Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR) [ Time Frame: 5 years ]
    Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

  75. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  76. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) [ Time Frame: 30 days ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  77. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) [ Time Frame: 180 days ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  78. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) [ Time Frame: 1 year ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  79. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) [ Time Frame: 2 years ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  80. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) [ Time Frame: 3 years ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  81. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) [ Time Frame: 4 years ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)

  82. Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR) [ Time Frame: 5 years ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)

  83. Number of Participants With DMR (All Death, All MI, All Revascularization) [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]
    DMR is the composite of All Death, All MI, All Revascularization

  84. Number of Participants With DMR (All Death, All MI, All Revascularization) [ Time Frame: 30 days ]
    DMR is the composite of All Death, All MI, All Revascularization.

  85. Number of Participants With DMR (All Death, All MI, All Revascularization) [ Time Frame: 180 days ]
    DMR is the composite of All Death, All MI, All Revascularization.

  86. Number of Participants With DMR (All Death, All MI, All Revascularization) [ Time Frame: 1 year ]
    DMR is the composite of All Death, All MI, All Revascularization.

  87. Number of Participants With DMR (All Death, All MI, All Revascularization) [ Time Frame: 2 years ]
    DMR is the composite of All Death, All MI, All Revascularization.

  88. Number of Participants With DMR (All Death, All MI, All Revascularization) [ Time Frame: 3 years ]
    DMR is the composite of All Death, All MI, All Revascularization.

  89. Number of Participants With DMR (All Death, All MI, All Revascularization) [ Time Frame: 4 years ]
    DMR is the composite of All Death, All MI, All Revascularization

  90. Number of Participants With DMR (All Death, All MI, All Revascularization) [ Time Frame: 5 years ]
    DMR is the composite of All Death, All MI, All Revascularization

  91. Number of Participants Experiencing Cardiac Death/All MI [ Time Frame: In-hospital (≤ 7 days of post index procedure) ]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    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


  92. Number of Participants Experiencing Cardiac Death/All MI [ Time Frame: 30 days ]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    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.

  93. Number of Participants Experiencing Cardiac Death/All MI [ Time Frame: 180 days ]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    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.

  94. Number of Participants Experiencing Cardiac Death/All MI [ Time Frame: 1 year ]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    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.

  95. Number of Participants Experiencing Cardiac Death/All MI [ Time Frame: 2 years ]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    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.

  96. Number of Participants Experiencing Cardiac Death/All MI [ Time Frame: 3 years ]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    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.

  97. Number of Participants Experiencing Cardiac Death/All MI [ Time Frame: 4 years ]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    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.


  98. Number of Participants Experiencing Cardiac Death/All MI [ Time Frame: 5 years ]

    Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.

    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.


  99. Number of Participants With Acute Stent/Scaffold Thrombosis [ Time Frame: <=1 day ]

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

    Timings:

    Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

    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;Nonocclusive/Occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus.

    Probable stent thrombosis may occur after intracoronary stenting due to:

    • Unexplained death within first 30 days
    • 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.

  100. Number of Participants With Subacute Stent/Scaffold Thrombosis [ Time Frame: > 1-30 days ]

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

    Timings:

    Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

    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;Nonocclusive/Occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus.

    Probable stent thrombosis may occur after intracoronary stenting due to:

    • Unexplained death within first 30 days
    • 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.

  101. Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis [ Time Frame: 0-30 days ]

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

    Timings:

    Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

    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;Nonocclusive/Occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus.

    Probable stent thrombosis may occur after intracoronary stenting due to:

    • Unexplained death within first 30 days
    • 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.

  102. Number of Participants With Late Stent/Scaffold Thrombosis [ Time Frame: 31-365 days ]

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

    Timings:

    Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

    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;Nonocclusive/Occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus.

    Probable stent thrombosis may occur after intracoronary stenting due to:

    • Unexplained death within first 30 days
    • 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.

  103. Number of Participants With Very Late Stent/Scaffold Thrombosis [ Time Frame: > 365 days ]

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

    Timings:

    Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

    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;Nonocclusive/Occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus.

    Probable stent thrombosis may occur after intracoronary stenting due to:

    • Unexplained death within first 30 days
    • 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.

  104. Number of Participants With Cumulative Stent/Scaffold Thrombosis [ Time Frame: 0-1853 days ]

    Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.

    Timings:

    Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.

    Definite stent thrombosis occurred by either angiographic/pathologic confirmation.

    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;Nonocclusive/Occlusive thrombus

    Pathological confirmation:Evidence of recent thrombus.

    Probable stent thrombosis may occur after intracoronary stenting due to:

    • Unexplained death within first 30 days
    • 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.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

General Inclusion Criteria

  • Subject must be at least 18 years of age and less than 85 years of age.
  • Subject must agree not to participate in any other clinical investigation for a period of three years following the index procedure. This includes clinical trials of medication and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
  • Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS system and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
  • Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia).
  • Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
  • Subject must agree to undergo all clinical investigation plan-required follow-up visits, exercise testing, blood draw as well as adherence to European Society of Cardiology Guidelines and completion of quality of life questionnaires and of a subject diary to collect information including but not limited to tobacco usage, food intake, daily exercise and body weight

Angiographic Inclusion Criteria

  • One or two de novo native lesions each located in a different epicardial vessel.
  • If two treatable lesions meet the eligibility criteria, they must be in separate major epicardial vessels (left anterior descending (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
  • Lesion(s) must have a visually estimated diameter stenosis of ≥50% and <100% with a TIMI flow of ≥1.
  • Lesion(s) must be located in a native coronary artery with Dmax by on-line quantitative coronary angiography (QCA) of ≥2.25 mm and ≤3.8 mm.
  • Lesion(s) must be located in a native coronary artery with lesion(s) length by on-line QCA of ≤48 mm.
  • Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥30 days prior to or if planned to be done 2 years after the index procedure.
  • Percutaneous intervention for lesions in the target vessel are allowed if done >6 months prior to or if planned to be done 2 years after the index procedure.

Exclusion Criteria:

  • Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and prasugrel and ticlopidine, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
  • Subject has a known diagnosis of acute myocardial infarction (AMI) at any time preceding the index procedure and relevant cardiac enzymes (according to local standard hospital practice) have not returned within normal limits at the time of procedure.
  • Evidence of ongoing acute myocardial infarction in ECG prior to procedure
  • Subject has current unstable arrhythmias.
  • Left ventricular ejection fraction (LVEF) < 30%.
  • Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
  • Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure.
  • Subject is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, severe asthma requiring immunosuppressive medication, etc.).
  • Subject is receiving chronic anticoagulation therapy that can not be stopped and restarted according to local hospital standard procedures.
  • Elective surgery is planned within 2 years after the procedure that will require discontinuing either aspirin, clopidogrel, prasugrel or ticlopidine.
  • Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a white blood cell count of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  • Known renal insufficiency (e.g., estimated glomerular filtration rate <60 ml/kg/1.73m² or serum creatinine level of >2.5 mg/dL, or subject on dialysis).
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past 6 months.
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 years following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial)
  • Other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.
  • Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
  • Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.

Angiographic Exclusion Criteria

  • Target lesion which prevents adequate (residual stenosis at target lesion(s) is ≤ 40% by visual assessment) coronary pre-dilatation.
  • Target lesion in left main trunk.
  • Aorto-ostial target lesion (within 3 mm of the aorta junction).
  • Target lesion located within 2 mm of the origin of the LAD or LCX.
  • Target lesion located distal to a diseased (vessel irregularity per angiogram and >20% stenosed lesion) arterial or saphenous vein graft.
  • Target lesion involving a bifurcation lesion with side branch ≥2 mm in diameter, or with a side branch <2mm in diameter requiring guide wire protection or dilatation.
  • Total occlusion (TIMI flow 0), prior to wire crossing
  • Excessive tortuosity (≥ two 45° angles), or extreme angulation (≥90 °) proximal to or within the target lesion.
  • Restenotic from previous intervention
  • Heavy calcification proximal to or within the target lesion.
  • Target lesion involves myocardial bridge.
  • Target vessel contains thrombus as indicated in the angiographic images.
  • Additionally clinically significant lesion(s) (≥ 40% diameter stenosis by visual assessment) for which percutaneous coronary intervention may be required <2 years after the index procedure.
  • Subject has received brachytherapy in any epicardial vessel (including side branches)
  • Subject has a high probability that a procedure other than pre-dilatation and study device implantation and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon)

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): NCT01425281


Locations
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Belgium
Abbott Vascular International BVBA
Brussels, Belgium, 0886.537.933
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Patrick W. Serruys, MD, PhD Erasmus Medical Center
Principal Investigator: Bernard Chevalier, MD Institut Jacques Cartier (ICPS)

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

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01425281     History of Changes
Other Study ID Numbers: 10-393
CIV-11-10-002627 ( Other Identifier: EUDAMED )
First Posted: August 30, 2011    Key Record Dates
Results First Posted: September 4, 2019
Last Update Posted: September 4, 2019
Last Verified: July 2019
Keywords provided by Abbott Medical Devices:
Bioabsorbable
Coronary scaffold
Coronary Stent
Everolimus
Drug eluting stents
Angioplasty
Coronary artery disease
Total coronary occlusion
Coronary artery restenosis
Stent thrombosis
Myocardial ischemia
Coronary artery stenosis
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents