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Absorb IV Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02173379
Recruitment Status : Active, not recruiting
First Posted : June 25, 2014
Results First Posted : July 24, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:

ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. 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.

The ABSORB IV Randomized Controlled Trial (RCT) is designed to continue to evaluate the safety and effectiveness as well as the potential short and long-term benefits of Abbott Vascular Absorb™ Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System (once commercially available), as compared to the commercially approved, control stent XIENCE.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Artery Stenosis Coronary Disease Coronary Stenosis Device: Absorb BVS Device: XIENCE Not Applicable

Detailed Description:

ABSORB IV:

A. Primary Objective:

  • To evaluate 30-day clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
  • To evaluate long-term clinical outcomes of Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three denovo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.

B. Secondary Objectives:

  • To evaluate 1-year clinical outcomes of the Absorb BVS compared to XIENCE in the treatment of subjects with ischemic heart disease caused by up to three de novo native coronary artery lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel.
  • To evaluate the incidence of angina occurring within 1 year, with treatment of Absorb BVS compared to XIENCE.

The enrollment of the 2610 subjects in ABSORB IV will start after enrollment completion of the 2000 primary analysis subjects in ABSORB III. All registered subjects will have clinical follow-up at 30, 90, 180, 270 days and 1, 2, 3, 4, 5, 6 and 7 years.

Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

In addition, all 2610 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30 days,180 days, 1 year, 3 years and 5 years.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2610 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
Actual Study Start Date : July 2014
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : April 2022

Arm Intervention/treatment
Experimental: Absorb BVS
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System
Device: Absorb BVS
  • Scaffold diameters: 2.5, 3.0 and 3.5 mm
  • Scaffold lengths: 8, 12, 18, and 28 mm. 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.
  • Once Absorb GT1™ BVS System is commercially available, it can also be used in the ABSORB IV trial. Scaffold diameters: 2.5, 3.0 and 3.5 mm of and scaffold lengths: 8, 12, 18, 23, and 28 mm.
  • 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, XIENCE Alpine, XIENCE Pro (outside of the US only) and XIENCE ProX (outside of the US only)
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. The 3.25 mm is only available for XIENCE Xpedition
  • Stent lengths: 8, 12, 15, 18, 23, and 28 mm
  • 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 Target Lesion Failure (TLF) [ Time Frame: 30 days ]
    Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))


Secondary Outcome Measures :
  1. Powered TLF, Tested for Non-inferiority of Absorb BVS to XIENCE [ Time Frame: 1 year ]
    This analysis will consist of ~2610 subjects in ABSORB IV.

  2. Number of Participants With Powered Angina [ Time Frame: 30 days ]
    • Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).
    • This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first.

  3. Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis) [ Time Frame: In-hospital (≤ 7days) ]
    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.

  4. Number of Participants With Acute Success- Procedural Success (Subject Level Analysis) [ Time Frame: In-hospital (≤ 7days) ]
    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).

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

    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.

    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 Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 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.

    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 Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 90 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.

    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 Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 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.

    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 Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 270 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.

    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 Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 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.

    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 Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ 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.

    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 Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ 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.

    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 Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ 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.

    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 Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ 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.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.


  15. Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 6 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.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.


  16. Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 7 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.

    Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.


  17. Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  18. Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  19. Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  20. Number of Participants With Myocardial Infarction (MI) [ Time Frame: In-hospital (≤ 7 days post index procedure) ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

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

  22. Number of Participants With Myocardial Infarction (MI) [ Time Frame: 90 days ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

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

  24. Number of Participants With Myocardial Infarction (MI) [ Time Frame: 270 days ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

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

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

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

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

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

  30. Number of Participants With Myocardial Infarction (MI) [ Time Frame: 6 years ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  31. Number of Participants With Myocardial Infarction (MI) [ Time Frame: 7 years ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  32. Number of Participants With Myocardial Infarction (MI) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  33. Number of Participants With Myocardial Infarction (MI) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  34. Number of Participants With Myocardial Infarction (MI) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  35. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: In-hospital (≤ 7 days post index procedure) ]
    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 or not ischemia driven by the investigator prior to repeat angiography.

  36. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 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 or not ischemia driven by the investigator prior to repeat angiography.

  37. Number of Participants withTarget Lesion Revascularization (TLR) [ Time Frame: 90 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 or not ischemia driven by the investigator prior to repeat angiography.

  38. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 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 or not ischemia driven by the investigator prior to repeat angiography.

  39. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 270 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 or not ischemia driven by the investigator prior to repeat angiography.

  40. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 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 or not ischemia driven by the investigator prior to repeat angiography.

  41. Number of Participants With 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 or not ischemia driven by the investigator prior to repeat angiography.

  42. Number of Participants With 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 or not ischemia driven by the investigator prior to repeat angiography.

  43. Number of Participants With 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 or not ischemia driven by the investigator prior to repeat angiography.

  44. Number of Participants With 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 or not ischemia driven by the investigator prior to repeat angiography.

  45. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 6 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 or not ischemia driven by the investigator prior to repeat angiography.

  46. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 7 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 or not ischemia driven by the investigator prior to repeat angiography.

  47. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  48. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  49. Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

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

    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.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

  51. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 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.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

  52. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 90 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.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

  53. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 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. classified as: Ischemic driven TVR and Non-ischemic driven TVR.

    -TVR includes all TVR, excluding TLR


  54. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 270 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.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

  55. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 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.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

  56. Number of Participants With Target Vessel Revascularization (TVR) [ 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.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

  57. Number of Participants With Target Vessel Revascularization (TVR) [ 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.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

  58. Number of Participants With Target Vessel Revascularization (TVR) [ 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.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

  59. Number of Participants With Target Vessel Revascularization (TVR) [ 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.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

  60. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 6 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.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

  61. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 7 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.

    • TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.
    • TVR includes all TVR, excluding TLR

  62. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  63. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  64. Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  65. Number of Participants With All Coronary Revascularization [ Time Frame: In-hospital (≤ 7 days post index procedure) ]
    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  66. Number of Participants With All Coronary Revascularization [ Time Frame: 30 days ]
    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  67. Number of Participants With All Coronary Revascularization [ Time Frame: 90 days ]
    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  68. Number of Participants With All Coronary Revascularization [ Time Frame: 180 days ]
    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  69. Number of Participants With All Coronary Revascularization [ Time Frame: 270 days ]
    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  70. Number of Participants With All Coronary Revascularization [ Time Frame: 1 year ]
    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  71. Number of Participants With All Coronary Revascularization [ Time Frame: 2 years ]
    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  72. Number of Participants With All Coronary Revascularization [ Time Frame: 3 years ]
    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  73. Number of Participants With All Coronary Revascularization [ Time Frame: 4 years ]
    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  74. Number of Participants With All Coronary Revascularization [ Time Frame: 5 years ]
    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  75. Number of Participants With All Coronary Revascularization [ Time Frame: 6 years ]
    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  76. Number of Participants With All Coronary Revascularization [ Time Frame: 7 years ]
    Revascularization includes TLR, TVR excluding TLR, and non TVR.

  77. Number of Participants With All Coronary Revascularization [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  78. Number of Participants With All Coronary Revascularization [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  79. Number of Participants With All Coronary Revascularization [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  80. Number of Participants Experienced All Death/All MI [ Time Frame: In-hospital (≤ 7 days 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: Those MIs which are not Q-wave MI


  81. Number of Participants Experienced 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: Those MIs which are not Q-wave MI


  82. Number of Participants Experienced Death/All MI [ Time Frame: 90 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: Those MIs which are not Q-wave MI


  83. Number of Participants Experienced 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: Those MIs which are not Q-wave MI


  84. Number of Participants Experienced Death/All MI [ Time Frame: 270 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: Those MIs which are not Q-wave MI


  85. Number of Participants Experienced 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: Those MIs which are not Q-wave MI


  86. Number of Participants Experienced 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), 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: Those MIs which are not Q-wave MI


  87. Number of Participants Experienced 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), 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: Those MIs which are not Q-wave MI


  88. Number of Participants Experienced 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), 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: Those MIs which are not Q-wave MI


  89. Number of Participants Experienced 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: Those MIs which are not Q-wave MI


  90. Number of Participants Experienced Death/All MI [ Time Frame: 6 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: Those MIs which are not Q-wave MI


  91. Number of Participants Experienced Death/All MI [ Time Frame: 7 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: Those MIs which are not Q-wave MI


  92. Number of Participants Experienced Death/All MI [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  93. Number of Participants Experienced Death/All MI [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  94. Number of Participants Experienced Death/All MI [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

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

  96. Number of Participants Experienced Cardiac Death/All MI [ Time Frame: 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.

  97. Number of Participants Experienced Cardiac Death/All MI [ Time Frame: 90 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.

  98. Number of Participants Experienced Cardiac Death/All MI [ Time Frame: 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.

  99. Number of Participants Experienced Cardiac Death/All MI [ Time Frame: 270 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.

  100. Number of Participants Experienced Cardiac Death/All MI [ Time Frame: 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.

  101. Number of Participants Experienced 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.

  102. Number of Participants Experienced 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.

  103. Number of Participants Experienced 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.

  104. Number of Participants Experienced 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.

  105. Number of Participants Experienced Cardiac Death/All MI [ Time Frame: 6 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.

  106. Number of Participants Experienced Cardiac Death/All MI [ Time Frame: 7 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.

  107. Number of Participants Experienced Cardiac Death/All MI [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  108. Number of Participants Experienced Cardiac Death/All MI [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  109. Number of Participants Experienced Cardiac Death/All MI [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

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

  111. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 90 days ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

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

  113. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 270 days ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

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

  115. Number of Participants Experienced 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).

  116. Number of Participants Experienced 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).

  117. Number of Participants Experienced 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).

  118. Number of Participants Experienced 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).

  119. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 6 years ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  120. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 7 years ]
    Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

  121. Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  122. Number of Participants Expereienced Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  123. Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  124. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE) [ Time Frame: In-hospital (≤ 7 days 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).

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

  126. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 90 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).

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

  128. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 270 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).

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

  130. Number of Participants Experienced 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).

  131. Number of Participants Experienced 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).

  132. Number of Participants Experienced 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).

  133. Number of Participants Experienced 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).

  134. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 6 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).

  135. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 7 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).

  136. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  137. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  138. Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

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

  140. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [ 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).

  141. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [ Time Frame: 90 days ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  142. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [ 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).

  143. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [ Time Frame: 270 days ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  144. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [ 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).

  145. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (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).

  146. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (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).

  147. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (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).

  148. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (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).

  149. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [ Time Frame: 6 years ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  150. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [ Time Frame: 7 years ]
    Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

  151. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  152. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  153. Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  154. Number of Participants Experienced Death/All MI/All Revascularization (DMR) [ Time Frame: In-hospital (≤ 7 days post index procedure) ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  155. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 30 days ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  156. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 90 days ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  157. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 180 days ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  158. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 270 days ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  159. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 1 year ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  160. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 2 years ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  161. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 3 years ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  162. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 4 years ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  163. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 5 years ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  164. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 6 years ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  165. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 7 years ]
    DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

  166. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  167. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  168. Number of Participants Experienced Death/All MI/All Revascularization [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  169. Number of Participants With Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition) [ Time Frame: Acute (0 - 24 hours post stent implantation) ]
    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  170. Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: Subacute (>24 hours - 30 days post stent implantation) ]
    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  171. Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: Late (30 days - 1 year post stent implantation) ]
    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).

  172. Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition) [ Time Frame: Very late (>1 year post stent implantation) ]
    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained

  173. Number of Participants With Rehospitalization [ Time Frame: 30 days ]
    • Coronary artery disease (CAD) related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  174. Number of Participants With Rehospitalization [ Time Frame: 90 days ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  175. Number of Participants With Rehospitalization [ Time Frame: 180 days ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  176. Number of Participants With Rehospitalization [ Time Frame: 270 days ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  177. Number of Participants With Rehospitalization [ Time Frame: 1 year ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  178. Number of Participants With Rehospitalization [ Time Frame: 2 years ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  179. Number of Participants With Rehospitalization [ Time Frame: 3 years ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  180. Number of Participants With Rehospitalization [ Time Frame: 4 years ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  181. Number of Participants With Rehospitalization [ Time Frame: 5 years ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  182. Number of Participants With Rehospitalization [ Time Frame: 6 years ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  183. Number of Participants With Rehospitalization [ Time Frame: 7 years ]
    • CAD related
    • Cardiovascular, non-CAD related
    • Non-cardiovascular related

  184. Number of Participants With Rehospitalization [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  185. Number of Participants With Rehospitalization [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  186. Number of Participants With Rehospitalization [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  187. Number of Participants With Repeat Coronary Arteriography [ Time Frame: In-hospital (≤ 7 days post index procedure) ]
  188. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 30 days ]
  189. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 90 days ]
  190. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 180 days ]
  191. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 270 days ]
  192. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 1 year ]
  193. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 2 years ]
  194. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 3 years ]
  195. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 4 years ]
  196. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 5 years ]
  197. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 6 years ]
  198. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 7 years ]
  199. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  200. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  201. Number of Participants With Repeat Coronary Arteriography [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  202. Landmark Analysis on MACE and TVF and Their Components [ Time Frame: 3-4 years ]
  203. Landmark Analysis on MACE and TVF and Their Components [ Time Frame: 3-5 years ]
  204. Landmark Analysis on MACE and TVF and Their Components [ Time Frame: 3-6 years ]
  205. Landmark Analysis on MACE and TVF and Their Components [ Time Frame: 3-7 years ]
  206. Landmark Analysis on MACE and TVF and Their Components [ Time Frame: 3-8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  207. Landmark Analysis on MACE and TVF and Their Components [ Time Frame: 3-9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  208. Landmark Analysis on MACE and TVF and Their Components [ Time Frame: 3-10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  209. Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [ Time Frame: 3-4 years ]
  210. Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [ Time Frame: 3-5 years ]
  211. Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [ Time Frame: 3-6 years ]
  212. Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [ Time Frame: 3-7 years ]
  213. Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [ Time Frame: 3-8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  214. Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [ Time Frame: 3-9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  215. Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable) [ Time Frame: 3-10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  216. Number of Participants With Target Lesion Failure (TLF) [ Time Frame: 1 year ]
    The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)

  217. Number of Participants With Target Lesion Failure (TLF) [ Time Frame: 7 years ]
    The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)

  218. Number of Participants With Target Lesion Failure (TLF) [ Time Frame: 8 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  219. Number of Participants With Target Lesion Failure (TLF) [ Time Frame: 9 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  220. Number of Participants With Target Lesion Failure (TLF) [ Time Frame: 10 years ]
    Note: All registered subjects in ABSORB IV will potentially be followed up at 8 years and/or 9 years and/or 10 years via telephone contact/office visit if it is necessary as determined by the Sponsor.

  221. Number of Participants With Cumulative Stent/Scaffold Thrombosis [ Time Frame: 0 to 30 Days ]
    Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).


Other Outcome Measures:
  1. Patient Reported Outcomes [ Time Frame: Baseline ]

    Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

    The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

    The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.

    Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.


  2. Patient Reported Outcomes [ Time Frame: 1 month ]

    Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

    The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

    The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.

    Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.


  3. Patient Reported Outcomes [ Time Frame: 6 months ]

    Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

    The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

    The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.

    Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.


  4. Patient Reported Outcomes [ Time Frame: 1 year ]

    Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

    The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

    The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.

    Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.


  5. Patient Reported Outcomes [ Time Frame: 3 years ]

    Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

    The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

    The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.

    Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.


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

    Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.

    The following questionnaires will be used in this study:

    • Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life
    • EuroQoL 5D (EQ-5D) survey to assess overall health status

    (Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)

    The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.

    Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial.


  7. Landmark Analysis on TLF and Components [ Time Frame: 3-4 years ]
    TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).

  8. Landmark Analysis on TLF and Components [ Time Frame: 3-5 years ]
    TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).

  9. Landmark Analysis on TLF and Components [ Time Frame: 3-6 years ]
    TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).

  10. Landmark Analysis on TLF [ Time Frame: 3-7 years ]
    TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).

  11. Landmark Analysis on TLF and Components [ Time Frame: 3-8 years ]
    TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).

  12. Landmark Analysis on TLF and Components [ Time Frame: 3-9 years ]
    TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).

  13. Landmark Analysis on TLF and Components [ Time Frame: 3-10 years ]
    TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. Subject must be at least 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 (e.g., silent ischemia, stable or unstable angina, non-ST-segment elevation MI (NSTEMI), OR recent ST-segment elevation MI (STEMI). Patients with stable coronary syndromes can be enrolled any time after symptom onset if eligibility criteria are otherwise met. Patients with acute coronary syndrome can be enrolled under the following conditions:

    1. Unstable angina or NSTEMI within 2 weeks of the index procedure.
    2. STEMI > 72 hours ≤ 2 weeks prior to the index procedure.

    Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

  4. Subjects must be suitable for PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective signs of ischemia as determined by one of the following: abnormal stress echocardiogram, nuclear scan, electrocardiogram (ECG), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or fractional flow reserve (FFR).

    (Note: subject with silent ischemia must have a prior history of typical angina, angina-equivalent symptoms, or atypical angina within the past year to be included in the trial.)

  5. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  6. 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.
  7. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for at least 1 year following the index procedure.
  8. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 5 years following the index procedure.

Angiographic Inclusion Criteria:

Treatment of up to three de novo lesions in a maximum of two epicardial vessels, with a maximum of two lesions per epicardial vessel. If only a single lesion is to be treated, it must be a target lesion. Up to one non-target lesion can be treated. Non-target lesion treatment can occur only in a non-target vessel.

If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 15 mm apart per visual estimation; otherwise this is considered as a single target lesion for lesion (and stent) length determination and must be treated with a single study device.

1. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %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 ≤0.80 AND/OR a positive stress test), or presentation with an acute coronary syndrome (unstable angina or NSTEMI within 2 weeks of index procedure, or STEMI >72 hours but ≤ 2 weeks prior to the index procedure).

  1. Target lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
  2. Target lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.

Note: Subjects with Unstable angina (UA) or NSTEMI or STEMI occurring > 2 weeks of the index procedure can be included in the trial but should be categorized based on their current angina class.

Note: To exclude enrollment of excessively small vessels, if the operator believes that based on visual angiographic assessments, the distal reference vessel diameter is ≤ 2.75 mm such that the plan is to implant a 2.5 mm device (stent or scaffold) in a target lesion, it is strongly recommended that either on-line QCA or intravascular imaging (ultrasound or optical coherence tomography) is used and demonstrates that the measured distal RVD for this target lesion is ≥ 2.50 mm (by at least one of these imaging modalities). This measurement may be performed before or after pre-dilatation, but before randomization. If the distal RVD measures <2.5 mm, that lesion IS NOT ELIGIBLE for randomization. Such a lesion may be treated as a non-target lesion.

General Exclusion Criteria:

  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12 receptor inhibitor is planned within 12 months after the procedure.
  2. Subject has known 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. Subject has known allergic reaction, hypersensitivity or contraindication to any of the following: aspirin; or clopidogrel and prasugrel and ticagrelor; or heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
  4. Subject had an acute STEMI (appropriate clinical syndrome with ≥1 mm of ST-segment elevation in ≥2 contiguous leads) within 72 hours of the index procedure.
  5. Subject has a cardiac arrhythmia identified at the time of screening for which at least one of the following criteria is met:

    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.
  6. Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, multiple-gated acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed within 1 week of the index procedure and after ACS presentation, which may include contrast left ventriculography during the index procedure but prior to randomization in order to confirm the subject's eligibility.
  7. Subject has undergone prior 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 a minimum of 24 hours and 30 days before the index procedure if successful and uncomplicated.
  8. Subject requires future staged PCI of any lesion other than a target lesion identified at the time of index procedure; or subject requires future peripheral vascular interventions < 30 days after the index procedure.
  9. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  10. At the time of screening, the subject has a malignancy that is not in remission.
  11. 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.
  12. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
  13. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or any other related agent for any reason).
  14. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
  15. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  16. Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.
  17. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastrointestinal or significant urinary bleed within the past six months.
  18. Subject has had a 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.).
  19. Subject has 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.
  20. Subject has a life expectancy <5 years for any non-cardiac or cardiac cause.
  21. 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.
  22. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  23. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria:

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

  1. Unsuccessful pre-dilatation, defined as the presence of one or more of the following (note: successful pre-dilatation of at least one target lesion is required prior to randomization):

    1. Residual %diameter stenosis (DS) after pre-dilatation is ≥ 40% (per visual estimation). Note: achieving a %DS ≤ 20% prior to randomization is strongly recommended.
    2. TIMI flow grade <3 (per visual estimation).
    3. Any angiographic complication (e.g. distal embolization, side branch closure).
    4. Any dissection NHLBI grade D-F.
    5. Any chest pain lasting > 5 minutes.
    6. Any ST-segment depression or elevation lasting > 5 minutes.
  2. Lesion is located in left main or there is a ≥30% diameter stenosis in the left main (unless the left main lesion is a protected left main (i.e. a patent bypass graft to the LAD and/or LCX arteries is present), and there is no intention to treat the protected left main lesion).
  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 intravascular ultrasound (IVUS) used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
  7. Lesion or vessel involves a myocardial bridge.
  8. Vessel has been previously treated with a stent and the target lesion is within 5 mm proximal or distal to a previously stented lesion.
  9. 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): NCT02173379


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Banner Heart Hospital
Mesa, Arizona, United States, 85206
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, California
John Muir Medical Center
Concord, California, United States, 94520
Washington Hospital
Fremont, California, United States, 94538
Scripps Memorial Hospital, La Jolla
La Jolla, California, United States, 92037
Good Samaritan Hospital
Los Angeles, California, United States, 90017
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Ronald Regean UCLA Medical Center
Los Angeles, California, United States, 90066
UC Davis Medical Center
Sacramento, California, United States, 95817
Sutter Memorial Hospital
Sacramento, California, United States, 95819
Sharp Memorial Hospital
San Diego, California, United States, 92123
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Little Company Of Mary Hospital
Torrance, California, United States, 90503
Torrance Memorial Medical Center
Torrance, California, United States, 90505
United States, Colorado
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
St. Vincents Medical Center
Jacksonville, Florida, United States, 32204
Baptist Medical Center - Downtown
Jacksonville, Florida, United States, 32207
University of Florida - Jacksonville
Jacksonville, Florida, United States, 32209
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, United States, 33410
Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Emory University Midtown
Atlanta, Georgia, United States, 30308
Piedmont Hospital Atlanta
Atlanta, Georgia, United States, 30309
Emory University Hospital
Atlanta, Georgia, United States, 30322
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
St. John's Hospital
Springfield, Illinois, United States, 62769
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46514
Francisan St. Francis Health
Indianapolis, Indiana, United States, 46237
St Vincent Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
University of Kentucky
Lexington, Kentucky, United States, 40506
Jewish Hospital
Louisville, Kentucky, United States, 40202
Baptist Hospital East Louisville
Louisville, Kentucky, United States, 40207
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Washington Hospital Center
Boston, Massachusetts, United States, 02241-8203
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01605
United States, Michigan
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48197
Bay Regional Medical Center
Bay City, Michigan, United States, 48706
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Harper University Hospital
Detroit, Michigan, United States, 48201
St. John's Hospital and Medical Center
Detroit, Michigan, United States, 48236
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
Beaumont Hospitals
Royal Oak, Michigan, United States, 48073
United States, Mississippi
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801
United States, Missouri
Boone Hospital Center
Columbia, Missouri, United States, 65201
Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
Mercy Hospital - Springfield
Springfield, Missouri, United States, 65804
United States, Montana
St. Patrick Hospital
Missoula, Montana, United States, 59802
United States, Nebraska
Nebraska Heart Hospital
Lincoln, Nebraska, United States, 68526
Alegent Bergant - Omaha
Omaha, Nebraska, United States, 68124
United States, New Hampshire
Dartmouth Hitchcock Memorial Hospital
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Our Lady of Lourdes Medical Center
Camden, New Jersey, United States, 08103
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
Morristown Memorial MED CTR
Morristown, New Jersey, United States, 07960
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07754
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Queens Hospital
Flushing, New York, United States, 11355
New York Presbyterian Hospital-Cornell
New York, New York, United States, 10021
Mount Sinai Medical Center
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
Rochester General Hospital
Rochester, New York, United States, 14621
Strong Memorial Hospital
Rochester, New York, United States, 14642
Stony Brook Hospital and Medical Center
Stony Brook, New York, United States, 11794
St. Joseph's Hospital Health Center
Syracuse, New York, United States, 13203
United States, North Carolina
Carolinas Medical Center- North East
Charlotte, North Carolina, United States, 28203
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Carolinas Medical Center-Pineville
Charlotte, North Carolina, United States, 28210
Rex Hospital
Raleigh, North Carolina, United States, 27607
Wake Med
Raleigh, North Carolina, United States, 27610
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Aultman Hospital
Canton, Ohio, United States, 44710
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
Mercy St. Vincent Medical Center
Toledo, Ohio, United States, 43608
Genesis Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Sacred Heart Medical Center
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Bryn Mawr
Bryn Mawr, Pennsylvania, United States, 19010
Holy Spirit Hospital
Camp Hill, Pennsylvania, United States, 17011
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Doylestown Hospital
Doylestown, Pennsylvania, United States, 18901
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, United States, 17105-8700
West Shore Hospital
Harrisburg, Pennsylvania, United States, 17110
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Alleghany General Hospital
Pittsburgh, Pennsylvania, United States, 15212
UPMC
Pittsburgh, Pennsylvania, United States, 15213
St. Joseph Medical Center
Reading, Pennsylvania, United States, 19605
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Anmed Health
Anderson, South Carolina, United States, 29621
Providence Hospital
Columbia, South Carolina, United States, 29204
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
United States, South Dakota
Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117
United States, Tennessee
Memorial Hospital
Chattanooga, Tennessee, United States, 37404
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37660
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Northwest Texas Healthcare System
Amarillo, Texas, United States, 79106
Seton Medical Center Austin
Austin, Texas, United States, 78705
Baylor Heart and Vascular Hospital
Dallas, Texas, United States, 75226
Harrison Methodist
Fort Worth, Texas, United States, 76104
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
The Methodist Hospital
Houston, Texas, United States, 77030
East Texas Medical Center
Tyler, Texas, United States, 75701
United States, Virginia
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24014
Winchester Medical Center
Winchester, Virginia, United States, 22601
United States, Washington
Providence Everett Med Ctr
Everett, Washington, United States, 98201
Australia, New South Wales
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Prince of Wales Public Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
The Prince Charles Hospital
Brisbane, Queensland, Australia, 4032
Royal Brisbane Womens
Herston, Queensland, Australia, 4029
Australia, Victoria
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Epworth Healthcare Hospital
Richmond, Victoria, Australia, 3121
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Royal Perth Hospital
Perth, Western Australia, Australia, 6001
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2W 1T8
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Germany
Universitatsklinikum Freiburg
Freiburg, Baden-Württemberg, Germany, 79106
Ulm
Ulm, Baden-Württemberg, Germany, 89081
Kliniken Oberallgau gGmbH
Immenstadt, Bavaria, Germany, 87509
Klinikum Kempten, Klinikverbund Keptem-Oberallgae
Kempten-Allgau, Bavaria, Germany, 87439
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, Berlin, Germany, 16321
University Giessen
Giessen, Hesse, Germany, 35392
Oldenburg
Oldenburg, Lower Saxony, Germany, 26133
Universitatsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany, 53105
Elisabeth-Krankenhaus Essen
Essen, North Rhine-Westphalia, Germany, 45138
Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Segeberger Kliniken GmbH
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Study Chair: Gregg W Stone, MD Columbia University Medical Center, New York, NY
Principal Investigator: Gregg W Stone, MD Columbia University Medical Center, New York, NY
Principal Investigator: Stephen G Ellis, MD Cleveland Clinic, Cleveland OH
Principal Investigator: Dean J Kereiakes, MD The Christ Hospital, Cincinnati, OH
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Statistical Analysis Plan  [PDF] March 16, 2017
Study Protocol  [PDF] March 14, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02173379     History of Changes
Other Study ID Numbers: 10-392 C
First Posted: June 25, 2014    Key Record Dates
Results First Posted: July 24, 2018
Last Update Posted: November 1, 2018
Last Verified: October 2018

Keywords provided by Abbott Medical Devices:
Absorb™ BVS
Angioplasty
Bioabsorbable
BVS
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:
Layout table for 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