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Trial record 1 of 9 for:    ABSORB III
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ABSORB III Randomized Controlled Trial (RCT) (ABSORB-III)

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: NCT01751906
Recruitment Status : Active, not recruiting
First Posted : December 18, 2012
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

Brief Summary:

The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).

The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.


Condition or disease Intervention/treatment
Coronary Artery Disease Coronary Artery Stenosis Coronary Disease Coronary Stenosis Device: Absorb BVS Device: XIENCE

Detailed Description:

ABSORB III RCT:

A. Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

B. Powered Secondary Objectives:

  1. Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice.

    The lead-in phase is a non-randomized, single-arm, open label group of up to 50 subjects treated with Absorb BVS at up to 35 US sites. The Lead-In phase will enroll/register subjects prior to the randomization phase of ABSORB III.

    The Lead-In Phase allows the treatment of up to two de novo native coronary artery lesions in different epicardial vessels with reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 3.25 mm and lesion lengths ≥ 8 to ≤ 14 mm.

  2. Imaging Cohort Objective: To evaluate long-term vascular function and patency of the Absorb BVS treated segments compared to XIENCE treated segments in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

The imaging cohort-phase is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center trial, registering approximately 200 subjects. This includes 150 subjects for the angiographic/intravascular ultrasound (IVUS) endpoints analysis and approximately 50 subjects for optical coherence tomography (OCT) endpoints analysis. The 200 subjects are separate from the 2000 subjects included in the primary analysis. Data from two powered secondary endpoints from this cohort will support label claims of superiority of Absorb BVS as compared to XIENCE specific to vasomotion and late lumen enlargement.

All other subjects in ABSORB III unless specified will receive treatment of up to two de novo native coronary artery lesions in different epicardial vessels with RVD ≥ 2.5 mm to ≤ 3.75 mm and lesion lengths ≤ 24 mm.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2008 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions.
Study Start Date : December 2012
Primary Completion Date : September 2016
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Absorb BVS
Subjects receiving Absorb BVS
Device: Absorb BVS
  • Scaffold diameters: 2.5, 3.0 and 3.5 mm
  • Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
  • The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.

Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Active Comparator: XIENCE
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
Device: XIENCE

Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).

  • Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
  • Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
  • For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices

To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.




Primary Outcome Measures :
  1. Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 1 year ]
    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).


Secondary Outcome Measures :
  1. Acute Success- Device Success (Lesion Level Analysis) [ Time Frame: On day 0 (the day of procedure) ]
    Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.

  2. Acute Success: Procedural Success (Subject Level Analysis) [ Time Frame: On day 0 (the day of procedure) ]
    Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) 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 (maximum of 7 days).

  3. Number of Participants With Powered Secondary Endpoint: Angina [ Time Frame: 1 year ]
    Angina is defined as the first adverse event resulting in the site diagnosis of angina.

  4. Number of Participants With Powered Secondary Endpoint: All Revascularization [ Time Frame: 1 year ]
    This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.

  5. Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR) [ Time Frame: 1 year ]
    This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.

  6. Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]

    DEATH (Per Academic Research Consortium (ARC)) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    Cardiac death (CD): 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 With Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 0 to 30 days ]

    DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    Cardiac death (CD): 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 With Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 0 to 180 days ]

    DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    Cardiac death (CD): 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 With Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 0 to 1 year ]

    DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    Cardiac death (CD): 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 With Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 2 years ]

    DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    Cardiac death (CD): 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 Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 3 years ]

    DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    Cardiac death (CD): 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.


  12. Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 4 years ]

    DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    Cardiac death (CD): 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.


  13. Number of Participants With Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 5 years ]

    DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

    Cardiac death (CD): 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 Myocardial Infarction (MI) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  15. Number of Participants With All Myocardial Infarction (MI) [ Time Frame: 0 to 30 days ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  16. Number of Participants With All Myocardial Infarction (MI) [ Time Frame: 0 to 180 days ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  17. Number of Participants With All Myocardial Infarction (MI) [ Time Frame: 0 to 1 year ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  18. Number of Participants With All Myocardial Infarction (MI) [ Time Frame: 2 years ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  19. Number of Participants With All Myocardial Infarction (MI) [ Time Frame: 3 years ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  20. Number of Participants With All Myocardial Infarction (MI) [ Time Frame: 4 years ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  21. Number of Participants With All Myocardial Infarction (MI) [ Time Frame: 5 years ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

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

    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. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.

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


  23. Number of Participants With All Target Lesion Revascularization (TLR) [ Time Frame: 0 to 30 days ]

    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. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.

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


  24. Number of Participants With All Target Lesion Revascularization (TLR) [ Time Frame: 0 to 180 days ]

    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. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.

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


  25. Number of Participants With All Target Lesion Revascularization (TLR) [ Time Frame: 0 to 1 year ]

    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. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.

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


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

    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. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.

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


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

    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. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.

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


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

    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. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.

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


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

    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. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.

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


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

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    Target Vessel Revascularization (TVR,) excluding TLR includes:

    • ID-TVR excluding TLR.
    • Non-ID TVR excluding TLR.

  31. Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR) [ Time Frame: 0 to 30 days ]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    Target Vessel Revascularization (TVR,) excluding TLR includes:

    • ID-TVR excluding TLR.
    • Non-ID TVR excluding TLR.

  32. Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR) [ Time Frame: 0 to 180 days ]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    Target Vessel Revascularization (TVR,) excluding TLR includes:

    • ID-TVR excluding TLR.
    • Non-ID TVR excluding TLR.

  33. Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR) [ Time Frame: 0 to 1 year ]

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.

    Target Vessel Revascularization (TVR,) excluding TLR includes:

    • ID-TVR excluding TLR.
    • Non-ID TVR excluding TLR.

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

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

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

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

  38. Number of Participants With All Revascularization [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  39. Number of Participants With All Revascularization [ Time Frame: 0 to 30 days ]
    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  40. Number of Participants With All Revascularization [ Time Frame: 0 to 180 days ]
    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  41. Number of Participants With All Revascularization [ Time Frame: 2 years ]
    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  42. Number of Participants With All Revascularization [ Time Frame: 3 years ]
    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  43. Number of Participants With All Revascularization [ Time Frame: 4 years ]
    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  44. Number of Participants With All Revascularization [ Time Frame: 5 years ]
    All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

  45. Number of Participants With Death/All MI [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  46. Number of Participants With Death/All MI [ Time Frame: 0 to 30 days ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  47. Number of Participants With Death/All MI [ Time Frame: 0 to 180 days ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  48. Number of Participants With Death/All MI [ 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 patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  49. Number of Participants With Death/All MI [ Time Frame: 2 years ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  50. Number of Participants With Death/All MI [ Time Frame: 3 years ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  51. Number of Participants With Death/All MI [ Time Frame: 4 years ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

  52. Number of Participants With Death/All MI [ Time Frame: 5 years ]
    All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

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

  54. Number of Participants With Cardiac Death/All MI [ Time Frame: 0 to 30 days ]
    Cardiac death (CD): 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.

  55. Number of Participants With Cardiac Death/All MI [ Time Frame: 0 to 180 days ]
    Cardiac death (CD): 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.

  56. Number of Participants With Cardiac Death/All MI [ Time Frame: 0 to 1 year ]
    Cardiac death (CD): 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.

  57. Number of Participants With Cardiac Death/All MI [ Time Frame: 2 years ]
    Cardiac death (CD): 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.

  58. Number of Participants With Cardiac Death/All MI [ Time Frame: 3 years ]
    Cardiac death (CD): 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.

  59. Number of Participants With Cardiac Death/All MI [ Time Frame: 4 years ]
    Cardiac death (CD): 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.

  60. Number of Participants With Cardiac Death/All MI [ Time Frame: 5 years ]
    Cardiac death (CD): 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.

  61. Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    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 Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 0 to 30 days ]
    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 Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 0 to 180 days ]
    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 Cardiac Death/TV-MI/ID-TLR (TLF) [ 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).

  65. Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF) [ 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).

  66. Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF) [ 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).

  67. Number of Participants With Cardiac Death/TV-MI/ID-TLR (TLF) [ 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).

  68. Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    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 Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 0 to 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).

  70. Number of Participants With Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 0 to 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).

  71. Number of Participants With Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 0 to 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).

  72. Number of Participants With Cardiac Death/All MI/ID-TLR (MACE) [ 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).

  73. Number of Participants With Cardiac Death/All MI/ID-TLR (MACE) [ 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).

  74. Number of Participants With Cardiac Death/All MI/ID-TLR (MACE) [ 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).

  75. Number of Participants With Cardiac Death/All MI/ID-TLR (MACE) [ 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).

  76. Number of Participants With Target Vessel Failure (TVF) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    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) [ Time Frame: 0 to 30 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) [ Time Frame: 0 to 180 days ]
    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) [ Time Frame: 0 to 1 year ]
    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) [ 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).

  81. Number of Participants With Target Vessel Failure (TVF) [ 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).

  82. Number of Participants With Target Vessel Failure (TVF) [ 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).

  83. Number of Participants With Target Vessel Failure (TVF) [ 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).

  84. Number of Participants With Death/All MI/All Revascularization (DMR) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    The composite of Death, All MI and All revascularization.

  85. Number of Participants With Death/All MI/All Revascularization (DMR) [ Time Frame: 0 to 30 days ]
    The composite of Death, All MI and All revascularization.

  86. Number of Participants With Death/All MI/All Revascularization (DMR) [ Time Frame: 0 to 180 days ]
    The composite of Death, All MI and All revascularization.

  87. Number of Participants With Death/All MI/All Revascularization (DMR) [ Time Frame: 0 to 1 year ]
    The composite of Death, All MI and All revascularization.

  88. Number of Participants With Death/All MI/All Revascularization (DMR) [ Time Frame: 2 years ]
    The composite of Death, All MI and All revascularization.

  89. Number of Participants With Death/All MI/All Revascularization (DMR) [ Time Frame: 3 years ]
    The composite of Death, All MI and All revascularization.

  90. Number of Participants With Death/All MI/All Revascularization (DMR) [ Time Frame: 4 years ]
    The composite of Death, All MI and All revascularization.

  91. Number of Participants With Death/All MI/All Revascularization (DMR) [ Time Frame: 5 years ]
    The composite of Death, All MI and All revascularization.

  92. Number of Participants With Acute Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: ≤ 1 Day ]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

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

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  93. Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: > 1 to 30 Days ]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

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

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  94. Number of Participants With Acute/Subacute Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: 0 to 30 days ]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

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

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  95. Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: 31 to 365 Days ]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

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

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  96. Number of Participants With Very Late Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: 366 to 393 Days ]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

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

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  97. Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: 0 to 393 Days ]

    Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.

    Timing :

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

    Evidence:

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.

    Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of

    • Any unexplained death within the first 30 days or
    • Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

  98. Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: 2 years ]
    Evidence (Definite, Probable and Possible)

  99. Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: 3 years ]
    Evidence (Definite, Probable and Possible)

  100. Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: 4 years ]
    Evidence (Definite, Probable and Possible)

  101. Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: 5 years ]
    Evidence (Definite, Probable and Possible)

  102. Pre-Procedure Minimum Lumen Diameter (MLD) [ Time Frame: < or = 1 day ]
    Angiographic endpoint

  103. Pre-Procedure Percent Diameter Stenosis (%DS) [ Time Frame: < or = 1 day ]
    Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

  104. Post-Procedure In-Segment Minimum Lumen Diameter (MLD) [ Time Frame: ≤ 7 days post index procedure ]
    Angiographic endpoint. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.

  105. Post-Procedure In-Device Minimum Lumen Diameter (MLD) [ Time Frame: ≤ 7 days post index procedure ]
    Angiographic endpoint.

  106. Post-Procedure In-Segment Percent Diameter Stenosis (%DS) [ Time Frame: ≤ 7 days post index procedure ]

    Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

    In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.


  107. Post-Procedure In-Device Percent Diameter Stenosis (%DS) [ Time Frame: ≤ 7 days post index procedure ]
    Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).

  108. Landmark Analysis on TLF and Components [ Time Frame: 1-3 years ]
  109. Landmark Analysis on TLF and Components [ Time Frame: 1-4 years ]
  110. Landmark Analysis on TLF and Components [ Time Frame: 1-5 years ]
  111. Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [ Time Frame: 1-3 years ]
  112. Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [ Time Frame: 1-4 years ]
  113. Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [ Time Frame: 1-5 years ]
  114. Powered Imaging Cohort Secondary Endpoint: The In-stent/Scaffold Mean Lumen Diameter Change, Between Pre- and Post-nitrate Infusion at 3 Years by Angiography [ Time Frame: 3 years ]
    Pooled angiographic subjects (~600 subjects): 200 subjects from the Imaging Cohort of ABSORB III and 400 subjects from the ABSORB Japan RCT.

  115. Powered Imaging Cohort Secondary Endpoint: The In-stent/Scaffold Mean Lumen Area Change, From Post-procedure to 3 Years by Intravascular Ultrasound (IVUS) [ Time Frame: 3 years ]
    • Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects.
    • Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.

  116. Optical Coherence Tomography (OCT) Endpoint [ Time Frame: 3 years ]

    All OCT endpoints will be collected for within the device and within the treated segment:

    Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions



Other Outcome Measures:
  1. Patient Reported Outcomes (PRO): Overall Health Status [ Time Frame: Baseline ]

    Overall health status assessed using the EuroQoL 5D (EQ-5D™).

    EQ-5D:

    • Scale range: 0 to 1
    • Higher values represent better outcomes
    • Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status.

  2. Patient Reported Outcomes (PRO): Overall Health Status [ Time Frame: 1 month ]

    Overall health status assessed using the EuroQoL 5D (EQ-5D™).

    EQ-5D:

    • Scale range: 0 to 1
    • Higher values represent better outcomes
    • Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status.

  3. Patient Reported Outcomes (PRO): Overall Health Status [ Time Frame: 12 months ]

    Overall health status assessed using the EuroQoL 5D (EQ-5D™).

    EQ-5D:

    • Scale range: 0 to 1
    • Higher values represent better outcomes
    • Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status.

  4. Patient Reported Outcomes (PRO): Anxiety [ Time Frame: Baseline ]

    Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).

    GAD-7:

    • Scale range: 0 to 21
    • Lower values represent better outcomes
    • No subscales

  5. Patient Reported Outcomes (PRO): Anxiety [ Time Frame: 1 month ]

    Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).

    GAD-7:

    • Scale range: 0 to 21
    • Lower values represent better outcomes
    • No subscales

  6. Patient Reported Outcomes (PRO): Anxiety [ Time Frame: 12 months ]

    Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).

    GAD-7:

    • Scale range: 0 to 21
    • Lower values represent better outcomes
    • No subscales

  7. Patient Reported Outcomes (PRO): Disease-Specific Quality of Life [ Time Frame: Baseline ]

    Disease-Specific quality of life assessed using the Seattle Angina Questionnaire (SAQ)

    Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).


  8. Patient Reported Outcomes (PRO): Disease-Specific Quality of Life [ Time Frame: 1 month ]

    Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ).

    Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).


  9. Patient Reported Outcomes (PRO): Disease-Specific Quality of Life [ Time Frame: 12 months ]

    Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ).

    Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).


  10. Patient Reported Outcomes (PRO): Dyspnea Severity [ Time Frame: Baseline ]

    Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).

    Rose Dyspnea Scale:

    • Scale range: 0 to 4
    • Lower values represent better outcomes (higher scores indicate worse dyspnea)
    • No subscales

  11. Patient Reported Outcomes (PRO): Dyspnea Severity [ Time Frame: 1 month ]

    Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).

    Rose Dyspnea Scale:

    • Scale range: 0 to 4
    • Lower values represent better outcomes (higher scores indicate worse dyspnea)
    • No subscales

  12. Patient Reported Outcomes (PRO): Dyspnea Severity [ Time Frame: 12 months ]

    Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).

    Rose Dyspnea Scale:

    • Scale range: 0 to 4
    • Lower values represent better outcomes (higher scores indicate worse dyspnea)
    • No subscales

  13. Patient Reported Outcomes (PRO) [ Time Frame: 2 years ]

    In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.

    • Overall Health Status
    • Disease-Specific Quality of Life
    • Dyspnea severity
    • Anxiety

  14. Patient Reported Outcomes (PRO) [ Time Frame: 3 years ]

    In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.

    • Overall Health Status
    • Disease-Specific Quality of Life
    • Dyspnea severity
    • Anxiety

  15. Patient Reported Outcomes (PRO) [ Time Frame: 4 years ]

    In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.

    • Overall Health Status
    • Disease-Specific Quality of Life
    • Dyspnea severity
    • Anxiety

  16. Patient Reported Outcomes (PRO) [ Time Frame: 5 years ]

    In the 2000 primary analysis subjects of ABSORB III the following Patient Reported Outcomes will be analyzed as informational endpoints.

    • Overall Health Status
    • Disease-Specific Quality of Life
    • Dyspnea severity
    • Anxiety



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

General Inclusion Criteria:

  1. 18 years of age.
  2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
  3. Subject must have evidence of myocardial ischemia. In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.
  4. Acceptable candidate for coronary artery bypass graft (CABG) surgery.
  5. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.
  6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
  7. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.

General Exclusion Criteria:

  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an adenosine diphosphate (ADP) antagonist is planned within 12 months after the procedure.
  2. Hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
  3. Allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
  4. Acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the index procedure and both creatine kinase (CK) and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
  5. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
  6. Cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:

    (NOTE: Investigator should use discretion when enrolling subjects with high CHADS scores)

    1. Subject requires coumadin or any other agent for chronic oral anticoagulation
    2. Subject is likely to become hemodynamically unstable due to their arrhythmia
    3. Subject has poor survival prognosis due to their arrhythmia
  7. Left ventricular ejection fraction (LVEF) < 30%.
  8. Subject has undergone prior percutaneous coronary intervention (PCI) within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
  9. Future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure.
  10. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  11. At the time of screening, the subject has a malignancy that is not in remission.
  12. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
  13. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
  14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).
  15. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
  16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  17. Renal insufficiency. NOTE: Estimated glomerular filtration rate (GFR) can be based on Modification of Diet in Renal Disease (MDRD) equation or Cockcroft-Gault equation (CCG).
  18. High risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.
  19. Cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.).
  20. Extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.
  21. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.
  22. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.
  23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  24. Vulnerable population.

Angiographic Inclusion Criteria:

  1. One or two de novo target lesions:

    1. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
    2. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
    3. The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
  2. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed % diameter stenosis (DS) of ≥ 50% and < 100% with a thrombolysis in myocardial infarction (TIMI) flow of ≥1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g. fractional flow reserve, stress test), unstable angina or post-infarct angina.

    1. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.5 mm and ≤ 3.75 mm.
    2. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.
    3. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

  1. Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:

    1. Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is strongly recommended.
    2. TIMI Grade-3 flow (per visual estimation).
    3. No angiographic complications (e.g. distal embolization, side branch closure).
    4. No dissections National Heart Lung and Blood Institute (NHLBI) grade D-F.
    5. No chest pain lasting > 5 minutes.
    6. No ST depression or elevation lasting > 5 minutes
  2. Lesion is located in left main.
  3. Aorto-ostial right coronary artery (RCA) lesion (within 3 mm of the ostium).
  4. Lesion located within 3 mm of the origin of the Left Anterior Descending Artery (LAD) or left circumflex artery (LCX).
  5. Lesion involving a bifurcation with a:

    1. side branch ≥ 2 mm in diameter, or
    2. side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or
    3. side branch requiring dilatation.
  6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:

    1. Extreme angulation (≥ 90°) proximal to or within the target lesion.
    2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
    3. Moderate or heavy calcification proximal to or within the target lesion. If IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
  7. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.
  8. Lesion or vessel involves a myocardial bridge.
  9. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach the target lesion.
  10. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
  11. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

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): NCT01751906


  Show 195 Study Locations
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Stephen G Ellis, MD Cleveland Clinic, Cleveland OH
Principal Investigator: Dean J Kereiakes, MD The Christ Hospital, Cincinnati, OH
Study Chair: Gregg W Stone, MD Columbia University Medical Center, New York, NY
Study Director: Jennifer McMeans Jones Abbott Vascular

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

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01751906     History of Changes
Other Study ID Numbers: 10-392
First Posted: December 18, 2012    Key Record Dates
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018
Last Verified: January 2018

Keywords provided by Abbott Vascular:
Absorb™ BVS
Angioplasty
Bioabsorbable
BVS
Bioresorbable
Coronary Artery Disease
Coronary Artery Endothelial Responsiveness
Coronary artery restenosis
Coronary artery stenosis
Coronary scaffold
Coronary Stent
Drug eluting stents
Everolimus
Myocardial ischemia
Stent thrombosis
Stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Constriction, Pathologic
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs