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History of Changes for Study: NCT02173379
Absorb IV Randomized Controlled Trial
Latest version (submitted July 8, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 24, 2014 None (earliest Version on record)
2 August 7, 2014 Recruitment Status, Outcome Measures, Contacts/Locations, Study Status, Study Description, Eligibility and Arms and Interventions
3 September 18, 2014 Contacts/Locations and Study Status
4 November 11, 2014 Contacts/Locations and Study Status
5 February 9, 2015 Outcome Measures, Study Status, Contacts/Locations and Arms and Interventions
6 July 17, 2015 Study Status, Eligibility, Arms and Interventions and Study Description
7 February 9, 2016 Contacts/Locations and Study Status
8 September 26, 2016 Outcome Measures, Arms and Interventions, Study Description, Study Status and Eligibility
9 July 13, 2017 Recruitment Status, Outcome Measures, Study Status, Contacts/Locations, Study Design, Study Description
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Results Submission Events
10 June 27, 2018 Outcome Measures, Study Status, Document Section, Results, Contacts/Locations and Arms and Interventions
11 August 10, 2018 Outcome Measures and Study Status
12 October 3, 2018 Study Status
13 September 24, 2019 Outcome Measures, Study Status, Document Section, More Information, Study Description and Study Identification
14 November 4, 2019 Study Status
15 September 13, 2020 Outcome Measures, Adverse Events, Participant Flow, Baseline Characteristics, Study Status and Study Design
16 October 14, 2020 Outcome Measures and Study Status
17 May 3, 2021 Contacts/Locations and Study Status
18 March 19, 2022 Study Status
19 April 20, 2022 Study Status
20 July 8, 2022 Recruitment Status, Study Status, Outcome Measures
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Study NCT02173379
Submitted Date:  June 24, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 10-392 C
Brief Title: Absorb IV Randomized Controlled Trial
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2014
Overall Status: Not yet recruiting
Study Start: July 2014
Primary Completion: January 2016 [Anticipated]
Study Completion: January 2021 [Anticipated]
First Submitted: June 9, 2014
First Submitted that
Met QC Criteria:
June 24, 2014
First Posted: June 25, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 24, 2014
Last Update Posted: June 25, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Abbott Medical Devices
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 3000 subjects at approximately 132 sites. 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.
Detailed Description:

ABSORB IV:

A. Primary Objective:

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

The ABSORB IV trial will also include an imaging ischemia sub-study which will provide the physiological and mechanistic evaluation of whether PCI treatment with Absorb compared to XIENCE results in differences in myocardial ischemia in the early post-procedural period, and at 14 months and 62 months. The enrollment of the 3000 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, and 5 years, potentially at 6 and/or 7 years if it is necessary as determined by the Sponsor. In addition, all 3000 subjects in ABSORB IV will complete patient-reported outcome (PRO) self-administered questionnaires at baseline, 30, 90, 180, 270 days, and annually through 3 years.

Open or close this module Conditions
Conditions: Coronary Artery Disease
Coronary Artery Stenosis
Coronary Disease
Coronary Stenosis
Keywords: 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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 3000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Absorb BVS
Subjects receiving Absorb BVS
Device: Absorb BVS
  • Scaffold diameters: 2.5, 3.0 and 3.5 mm
  • Scaffold lengths: 8, 12, 18, and 28 mm. 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.

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

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

Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME and XIENCE Xpedition

  • Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
  • Stent lengths: 8, 12, 15, 18, 23, and 28 mm The 3.25 mm is only available for XIENCE Xpedition

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.

Open or close this module Outcome Measures
Primary Outcome Measures:
1. Angina Primary Endpoint: The percentage of patients who experienced angina within 1 year, tested first for non-inferiority with reflex to superiority against the control.
[ Time Frame: 1 year ]

  • 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.

    o For subjects who receive a planned staged procedure to treat one or more target lesions, the analysis will exclude angina or angina equivalent symptoms that occurred following the original index procedure through hospital discharge or 7 days after the final procedure, whichever occurs first.

  • This analysis will consist of ~3000 subjects in ABSORB IV.
2. Landmark TLF Primary Endpoint: TLF between 1 and 5 years, tested first for non-inferiority (NI) of Absorb BVS to XIENCE with reflex testing to superiority.
[ Time Frame: Between 1 and 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).
  • This analysis will consist of ~5000 subjects (2000 primary analysis subjects of ABSORB III and 3000 subjects of ABSORB IV).
Secondary Outcome Measures:
1. Powered Secondary Outcome: TLF through 1 year, tested for non-inferiority of Absorb BVS to XIENCE.
[ Time Frame: 1 year ]

This analysis will consist of ~3000 subjects in ABSORB IV.
2. Acute Success- Device success (Lesion level analysis)
[ Time Frame: Intraoperative ]

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 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.
3. Acute Success- Procedural success (Subject level analysis)
[ Time Frame: Intraoperative ]

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).
4. Death (Cardiac, Vascular, Non-cardiovascular)
[ Time Frame: Approximately 7 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. Myocardial Infarction (MI)
[ Time Frame: Approximately 7 days ]

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

  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
16. Myocardial Infarction (MI)
[ Time Frame: 90 days ]

  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
17. Myocardial Infarction (MI)
[ Time Frame: 180 days ]

  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
18. Myocardial Infarction (MI)
[ Time Frame: 270 days ]

  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
19. Myocardial Infarction (MI)
[ Time Frame: 1 year ]

  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
20. Myocardial Infarction (MI)
[ Time Frame: 2 years ]

  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
21. Myocardial Infarction (MI)
[ Time Frame: 3 years ]

  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
22. Myocardial Infarction (MI)
[ Time Frame: 4 years ]

  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
23. Myocardial Infarction (MI)
[ Time Frame: 5 years ]

  • Attributable to target vessel (TV-MI)
  • Not attributable to target vessel (NTV-MI)
24. Ischemia driven-Target Lesion Revascularization (ID-TLR)
[ Time Frame: Approximately 7 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.
25. Ischemia driven-Target Lesion Revascularization (ID-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.
26. Ischemia driven-Target Lesion Revascularization (ID-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.
27. Ischemia driven-Target Lesion Revascularization (ID-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.
28. Ischemia driven-Target Lesion Revascularization (ID-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.
29. Ischemia driven-Target Lesion Revascularization (ID-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.
30. Ischemia driven-Target Lesion Revascularization (ID-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.
31. Ischemia driven-Target Lesion Revascularization (ID-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.
32. Ischemia driven-Target Lesion Revascularization (ID-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.
33. Ischemia driven-Target Lesion Revascularization (ID-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.
34. Non ID-TLR (NID-TLR)
[ Time Frame: Approximately 7 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.
35. Non ID-TLR (NID-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.
36. Non ID-TLR (NID-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.
37. Non ID-TLR (NID-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.
38. Non ID-TLR (NID-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.
39. Non ID-TLR (NID-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.
40. Non ID-TLR (NID-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.
41. Non ID-TLR (NID-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.
42. Non ID-TLR (NID-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.
43. Non ID-TLR (NID-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.
44. Ischemia driven-Target Vessel Revascularization (ID-TVR)
[ Time Frame: Approximately 7 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.
45. Ischemia driven-Target Vessel Revascularization (ID-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.
46. Ischemia driven-Target Vessel Revascularization (ID-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.
47. Ischemia driven-Target Vessel Revascularization (ID-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.
48. Ischemia driven-Target Vessel Revascularization (ID-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.
49. Ischemia driven-Target Vessel Revascularization (ID-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.
50. Ischemia driven-Target Vessel Revascularization (ID-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.
51. Ischemia driven-Target Vessel Revascularization (ID-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.
52. Ischemia driven-Target Vessel Revascularization (ID-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.
53. Ischemia driven-Target Vessel Revascularization (ID-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.
54. Non ID-TVR (NID-TVR)
[ Time Frame: Approximately 7 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.
55. Non ID-TVR (NID-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.
56. Non ID-TVR (NID-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.
57. Non ID-TVR (NID-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.
58. Non ID-TVR (NID-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.
59. Non ID-TVR (NID-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.
60. Non ID-TVR (NID-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.
61. Non ID-TVR (NID-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.
62. Non ID-TVR (NID-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.
63. Non ID-TVR (NID-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.
64. All coronary revascularization
[ Time Frame: Approximately 7 days ]

65. All coronary revascularization
[ Time Frame: 30 days ]

66. All coronary revascularization
[ Time Frame: 90 days ]

67. All coronary revascularization
[ Time Frame: 180 days ]

68. All coronary revascularization
[ Time Frame: 270 days ]

69. All coronary revascularization
[ Time Frame: 1 year ]

70. All coronary revascularization
[ Time Frame: 2 years ]

71. All coronary revascularization
[ Time Frame: 3 years ]

72. All coronary revascularization
[ Time Frame: 4 years ]

73. All coronary revascularization
[ Time Frame: 5 years ]

74. Death/All MI
[ Time Frame: Approximately 7 days ]

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

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
76. Death/All MI
[ Time Frame: 90 days ]

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

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
78. Death/All MI
[ Time Frame: 270 days ]

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
79. Death/All MI
[ Time Frame: 1 year ]

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

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

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

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

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
84. Cardiac Death/All MI
[ Time Frame: Approximately 7 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.
85. 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.
86. 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.
87. 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.
88. 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.
89. 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.
90. 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.
91. 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.
92. 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.
93. 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.
94. Cardiac Death/TV-MI/ID-TLR (TLF)
[ Time Frame: Approximately 7 days ]

95. Cardiac Death/TV-MI/ID-TLR (TLF)
[ Time Frame: 30 days ]

96. Cardiac Death/TV-MI/ID-TLR (TLF)
[ Time Frame: 90 days ]

97. Cardiac Death/TV-MI/ID-TLR (TLF)
[ Time Frame: 180 days ]

98. Cardiac Death/TV-MI/ID-TLR (TLF)
[ Time Frame: 270 days ]

99. Cardiac Death/TV-MI/ID-TLR (TLF)
[ Time Frame: 1 year ]

100. Cardiac Death/TV-MI/ID-TLR (TLF)
[ Time Frame: 2 years ]

101. Cardiac Death/TV-MI/ID-TLR (TLF)
[ Time Frame: 3 years ]

102. Cardiac Death/TV-MI/ID-TLR (TLF)
[ Time Frame: 4 years ]

103. Cardiac Death/TV-MI/ID-TLR (TLF)
[ Time Frame: 5 years ]

104. Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
[ Time Frame: Approximately 7 days ]

105. Cardiac Death/All MI/ID-TLR (MACE)
[ Time Frame: 30 days ]

106. Cardiac Death/All MI/ID-TLR (MACE)
[ Time Frame: 90 days ]

107. Cardiac Death/All MI/ID-TLR (MACE)
[ Time Frame: 180 days ]

108. Cardiac Death/All MI/ID-TLR (MACE)
[ Time Frame: 270 days ]

109. Cardiac Death/All MI/ID-TLR (MACE)
[ Time Frame: 1 year ]

110. Cardiac Death/All MI/ID-TLR (MACE)
[ Time Frame: 2 years ]

111. Cardiac Death/All MI/ID-TLR (MACE)
[ Time Frame: 3 years ]

112. Cardiac Death/All MI/ID-TLR (MACE)
[ Time Frame: 4 years ]

113. Cardiac Death/All MI/ID-TLR (MACE)
[ Time Frame: 5 years ]

114. Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (Target Vessel Failure, TVF)
[ Time Frame: Approximately 7 days ]

115. Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF)
[ Time Frame: 30 days ]

116. Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF)
[ Time Frame: 90 days ]

117. Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF)
[ Time Frame: 180 days ]

118. Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF)
[ Time Frame: 270 days ]

119. Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF)
[ Time Frame: 1 year ]

120. Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF)
[ Time Frame: 2 years ]

121. Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF)
[ Time Frame: 3 years ]

122. Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF)
[ Time Frame: 4 years ]

123. Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (TVF)
[ Time Frame: 5 years ]

124. Death/All MI/All revascularization
[ Time Frame: Approximately 7 days ]

125. Death/All MI/All revascularization
[ Time Frame: 30 days ]

126. Death/All MI/All revascularization
[ Time Frame: 90 days ]

127. Death/All MI/All revascularization
[ Time Frame: 180 days ]

128. Death/All MI/All revascularization
[ Time Frame: 270 days ]

129. Death/All MI/All revascularization
[ Time Frame: 1 year ]

130. Death/All MI/All revascularization
[ Time Frame: 2 years ]

131. Death/All MI/All revascularization
[ Time Frame: 3 years ]

132. Death/All MI/All revascularization
[ Time Frame: 4 years ]

133. Death/All MI/All revascularization
[ Time Frame: 5 years ]

134. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: Approximately 7 days ]

Timing (acute, sub-acute, late and very late)
135. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 30 days ]

Timing (acute, sub-acute, late and very late)
136. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 90 days ]

Timing (acute, sub-acute, late and very late)
137. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 180 days ]

Timing (acute, sub-acute, late and very late)
138. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 270 days ]

Timing (acute, sub-acute, late and very late)
139. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 1 year ]

Timing (acute, sub-acute, late and very late)
140. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 2 years ]

Timing (acute, sub-acute, late and very late)
141. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 3 years ]

Timing (acute, sub-acute, late and very late)
142. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 4 years ]

Timing (acute, sub-acute, late and very late)
143. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 5 years ]

Timing (acute, sub-acute, late and very late)
144. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: Approximately 7 days ]

Evidence (Definite, Probable and Possible)
145. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 30 days ]

Evidence (Definite, Probable and Possible)
146. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 90 days ]

Evidence (Definite, Probable and Possible)
147. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 180 days ]

Evidence (Definite, Probable and Possible)
148. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 270 days ]

Evidence (Definite, Probable and Possible)
149. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 1 year ]

Evidence (Definite, Probable and Possible)
150. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 2 years ]

Evidence (Definite, Probable and Possible)
151. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 3 years ]

Evidence (Definite, Probable and Possible)
152. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 4 years ]

Evidence (Definite, Probable and Possible)
153. Scaffold/Stent Thrombosis (per ARC definition)
[ Time Frame: 5 years ]

Evidence (Definite, Probable and Possible)
154. Rehospitalization
[ Time Frame: 30 days ]

  • Coronary artery disease (CAD) related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
155. Rehospitalization
[ Time Frame: 90 days ]

  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
156. Rehospitalization
[ Time Frame: 180 days ]

  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
157. Rehospitalization
[ Time Frame: 270 days ]

  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
158. Rehospitalization
[ Time Frame: 1 year ]

  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
159. Rehospitalization
[ Time Frame: 2 years ]

  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
160. Rehospitalization
[ Time Frame: 3 years ]

  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
161. Rehospitalization
[ Time Frame: 4 years ]

  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
162. Rehospitalization
[ Time Frame: 5 years ]

  • CAD related
  • Cardiovascular, non-CAD related
  • Non-cardiovascular related
163. Repeat coronary arteriography
[ Time Frame: Approximately 7 days ]

164. Repeat coronary arteriography
[ Time Frame: 30 days ]

165. Repeat coronary arteriography
[ Time Frame: 90 days ]

166. Repeat coronary arteriography
[ Time Frame: 180 days ]

167. Repeat coronary arteriography
[ Time Frame: 270 days ]

168. Repeat coronary arteriography
[ Time Frame: 1 year ]

169. Repeat coronary arteriography
[ Time Frame: 2 years ]

170. Repeat coronary arteriography
[ Time Frame: 3 years ]

171. Repeat coronary arteriography
[ Time Frame: 4 years ]

172. Repeat coronary arteriography
[ Time Frame: 5 years ]

173. Landmark analysis on TLF and components
[ Time Frame: 1-2 years ]

174. Landmark analysis on TLF and components
[ Time Frame: 1-3 years ]

175. Landmark analysis on TLF and components
[ Time Frame: 1-4 years ]

176. Landmark analysis on TLF and components
[ Time Frame: 1-5 years ]

177. Landmark analysis on MACE and TVF and their components
[ Time Frame: 1-2 years ]

178. Landmark analysis on MACE and TVF and their components
[ Time Frame: 1-3 years ]

179. Landmark analysis on MACE and TVF and their components
[ Time Frame: 1-4 years ]

180. Landmark analysis on MACE and TVF and their components
[ Time Frame: 1-5 years ]

181. Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable)
[ Time Frame: 1-2 years ]

182. Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable)
[ Time Frame: 1-3 years ]

183. Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable)
[ Time Frame: 1-4 years ]

184. Landmark analysis on scaffold thrombosis/stent thrombosis (per ARC definition, definite and probable)
[ Time Frame: 1-5 years ]

185. TLF through 1 year
[ Time Frame: 1 year ]

Based on 5000 subjects-2000 primary analysis subjects of ABSORB III and 3000 subjects of ABSORB IV
186. TLF through 5 years
[ Time Frame: 5 years ]

Based on 5000 subjects-2000 primary analysis subjects of ABSORB III and 3000 subjects of ABSORB IV
Other Outcome Measures:
1. Patient Reported Outcomes (PRO)
[ Time Frame: Approximately 7 days ]

PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
  • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

The PROs will be analyzed for the following:

  • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
  • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization
2. Patient Reported Outcomes (PRO)
[ Time Frame: 1 month ]

PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
  • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

The PROs will be analyzed for the following:

  • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
  • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization
3. Patient Reported Outcomes (PRO)
[ Time Frame: 3 months ]

PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
  • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

The PROs will be analyzed for the following:

  • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
  • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization
4. Patient Reported Outcomes (PRO)
[ Time Frame: 6 months ]

PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
  • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

The PROs will be analyzed for the following:

  • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
  • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization
5. Patient Reported Outcomes (PRO)
[ Time Frame: 9 months ]

PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
  • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

The PROs will be analyzed for the following:

  • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
  • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization
6. Patient Reported Outcomes (PRO)
[ Time Frame: 1 year ]

PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
  • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

The PROs will be analyzed for the following:

  • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
  • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization
7. Patient Reported Outcomes (PRO)
[ Time Frame: 2 years ]

PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
  • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

The PROs will be analyzed for the following:

  • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
  • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization
8. Patient Reported Outcomes (PRO)
[ Time Frame: 3 years ]

PRO endpoints will be evaluated in the 3000 subjects of ABSORB IV. The following questionnaires will be used in this study:

  • Seattle Angina Questionnaire (SAQ) to assess disease-specific Quality of Life
  • Rose Dyspnea Scale (RDS) to assess severity of dyspnea
  • EuroQoL 5D (EQ-5D) survey to assess overall health status

The PROs will be analyzed for the following:

  • Difference between the treatment arms at each time point: baseline, 1, 3, 6, 9 months, 1, 2, and 3 years
  • Determining the impact on the PROs when the patient has angina, a re-hospitalization or a revascularization
9. Health Economics
[ Time Frame: 1 year ]

The primary analysis is to compare the resource utilization and costs between the two treatment groups at 1, 2 and 3 years. If the rates of angina, hospitalizations or revascularizations are different between the two arms, a cost effectiveness analysis will be performed evaluating the cost of angina, hospitalizations or revascularizations avoided. These analyses will be performed in the 3000 subjects of ABSORB IV.
10. Health Economics
[ Time Frame: 2 years ]

The primary analysis is to compare the resource utilization and costs between the two treatment groups at 1, 2 and 3 years. If the rates of angina, hospitalizations or revascularizations are different between the two arms, a cost effectiveness analysis will be performed evaluating the cost of angina, hospitalizations or revascularizations avoided. These analyses will be performed in the 3000 subjects of ABSORB IV.
11. Health Economics
[ Time Frame: 3 years ]

The primary analysis is to compare the resource utilization and costs between the two treatment groups at 1, 2 and 3 years. If the rates of angina, hospitalizations or revascularizations are different between the two arms, a cost effectiveness analysis will be performed evaluating the cost of angina, hospitalizations or revascularizations avoided. These analyses will be performed in the 3000 subjects of ABSORB IV.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 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 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. Patients 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, ECG, PET, MRI, and/or fractional flow reserve (FFR).

    (Note: subject with silent ischemia must have a prior history of typical 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

  1. Treatment of up to three target de novo lesions, with a maximum of two target lesions per epicardial 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 should be considered a single target lesion for lesion (and stent) length determination and must be treated with a single study device.
  2. 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 TIMI flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve ≤0.80 AND/OR 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 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 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.

General Exclusion Criteria

  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or a P2Y12 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 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 during the last 12 months.
  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 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 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):
    • Residual %DS after pre-dilatation is > 40% (per visual estimation). Note: achieving a %DS ≤ 20% prior to randomization is strongly recommended.
    • TIMI flow grade <3 (per visual estimation).
    • Any angiographic complication (e.g. distal embolization, side branch closure).
    • Any dissection NHLBI grade D-F.
    • Any chest pain lasting > 5 minutes.
    • 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.
  3. Aorto-ostial RCA lesion (within 3 mm of the ostium).
  4. Lesion located within 3 mm of the origin of the LAD or LCX.
  5. Lesion involving a bifurcation with a:
    1. side branch ≥ 2 mm in diameter, or
    2. side branch with either an ostial or non-ostial lesion with diameter stenosis >50%, or
    3. side branch requiring dilatation
  6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:
    1. Extreme angulation (≥ 90°) proximal to or within the target lesion.
    2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
    3. Moderate or heavy calcification proximal to or within the target lesion. If IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.
  7. 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.
Open or close this module Contacts/Locations
Central Contact Person: Vicki Gashwiler
Telephone: 408-845-3000
Email: AbsorbRCT@abbott.com
Study Officials: Gregg W Stone, MD
Study Chair
Columbia University Medical Center, New York, NY
Stephen G Ellis, MD
Principal Investigator
Cleveland Clinic, Cleveland, OH
Dean J Kereiakes, MD
Principal Investigator
The Christ Hospital, Cincinnati, OH
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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