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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02173379




Registration number
NCT02173379
Ethics application status
Date submitted
9/06/2014
Date registered
25/06/2014
Date last updated
30/10/2023

Titles & IDs
Public title
Absorb IV Randomized Controlled Trial
Scientific 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 ID [1] 0 0
10-392 C
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Coronary Artery Stenosis 0 0
Coronary Disease 0 0
Coronary Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Absorb BVS
Treatment: Devices - XIENCE

Experimental: Absorb BVS - Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS) System, and the Absorb GT1™ BVS System

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)


Treatment: Devices: 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.

Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Target Lesion Failure (TLF)
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
TLF at 1-year, Non-inferiority Against the Control
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Angina at 1-year, Non-inferiority Against the Control
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis)
Timepoint [3] 0 0
In-hospital (= 7days)
Secondary outcome [4] 0 0
Number of Participants With Acute Success- Procedural Success (Subject Level Analysis)
Timepoint [4] 0 0
In-hospital (= 7days)
Secondary outcome [5] 0 0
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [5] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [6] 0 0
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [6] 0 0
30 days
Secondary outcome [7] 0 0
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [7] 0 0
90 days
Secondary outcome [8] 0 0
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [8] 0 0
180 days
Secondary outcome [9] 0 0
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [9] 0 0
270 days
Secondary outcome [10] 0 0
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [10] 0 0
1 year
Secondary outcome [11] 0 0
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [11] 0 0
2 years
Secondary outcome [12] 0 0
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [12] 0 0
3 years
Secondary outcome [13] 0 0
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [13] 0 0
4 years
Secondary outcome [14] 0 0
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Timepoint [14] 0 0
5 years
Secondary outcome [15] 0 0
Number of Participants With Myocardial Infarction (MI)
Timepoint [15] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [16] 0 0
Number of Participants With Myocardial Infarction (MI)
Timepoint [16] 0 0
30 days
Secondary outcome [17] 0 0
Number of Participants With Myocardial Infarction (MI)
Timepoint [17] 0 0
90 days
Secondary outcome [18] 0 0
Number of Participants With Myocardial Infarction (MI)
Timepoint [18] 0 0
180 days
Secondary outcome [19] 0 0
Number of Participants With Myocardial Infarction (MI)
Timepoint [19] 0 0
270 days
Secondary outcome [20] 0 0
Number of Participants With Myocardial Infarction (MI)
Timepoint [20] 0 0
1 year
Secondary outcome [21] 0 0
Number of Participants With Myocardial Infarction (MI)
Timepoint [21] 0 0
2 years
Secondary outcome [22] 0 0
Number of Participants With Myocardial Infarction (MI)
Timepoint [22] 0 0
3 years
Secondary outcome [23] 0 0
Number of Participants With Myocardial Infarction (MI)
Timepoint [23] 0 0
4 years
Secondary outcome [24] 0 0
Number of Participants With Myocardial Infarction (MI)
Timepoint [24] 0 0
5 years
Secondary outcome [25] 0 0
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Timepoint [25] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [26] 0 0
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Timepoint [26] 0 0
30 days
Secondary outcome [27] 0 0
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Timepoint [27] 0 0
90 days
Secondary outcome [28] 0 0
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Timepoint [28] 0 0
180 days
Secondary outcome [29] 0 0
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Timepoint [29] 0 0
270 days
Secondary outcome [30] 0 0
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Timepoint [30] 0 0
1 year
Secondary outcome [31] 0 0
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Timepoint [31] 0 0
2 year
Secondary outcome [32] 0 0
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Timepoint [32] 0 0
3 years
Secondary outcome [33] 0 0
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Timepoint [33] 0 0
4 years
Secondary outcome [34] 0 0
Number of Participants With Target Vessel Myocardial Infarction (TV-MI)
Timepoint [34] 0 0
5 years
Secondary outcome [35] 0 0
Number of Participants With Target Lesion Revascularization (TLR)
Timepoint [35] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [36] 0 0
Number of Participants With Target Lesion Revascularization (TLR)
Timepoint [36] 0 0
30 days
Secondary outcome [37] 0 0
Number of Participants withTarget Lesion Revascularization (TLR)
Timepoint [37] 0 0
90 days
Secondary outcome [38] 0 0
Number of Participants With Target Lesion Revascularization (TLR)
Timepoint [38] 0 0
180 days
Secondary outcome [39] 0 0
Number of Participants With Target Lesion Revascularization (TLR)
Timepoint [39] 0 0
270 days
Secondary outcome [40] 0 0
Number of Participants With Target Lesion Revascularization (TLR)
Timepoint [40] 0 0
1 year
Secondary outcome [41] 0 0
Number of Participants With Target Lesion Revascularization (TLR)
Timepoint [41] 0 0
2 years
Secondary outcome [42] 0 0
Number of Participants With Target Lesion Revascularization (TLR)
Timepoint [42] 0 0
3 years
Secondary outcome [43] 0 0
Number of Participants With Target Lesion Revascularization (TLR)
Timepoint [43] 0 0
4 years
Secondary outcome [44] 0 0
Number of Participants With Target Lesion Revascularization (TLR)
Timepoint [44] 0 0
5 years
Secondary outcome [45] 0 0
Number of Participants With Ischemia Driven TLR (ID-TLR)
Timepoint [45] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [46] 0 0
Number of Participants With Ischemia Driven TLR (ID-TLR)
Timepoint [46] 0 0
30 days
Secondary outcome [47] 0 0
Number of Participants With Ischemia Driven TLR (ID-TLR)
Timepoint [47] 0 0
90 days
Secondary outcome [48] 0 0
Number of Participants With Ischemia Driven TLR (ID-TLR)
Timepoint [48] 0 0
180 days
Secondary outcome [49] 0 0
Number of Participants With Ischemia Driven TLR (ID-TLR)
Timepoint [49] 0 0
270 days
Secondary outcome [50] 0 0
Number of Participants With Ischemia Driven TLR (ID-TLR)
Timepoint [50] 0 0
1 year
Secondary outcome [51] 0 0
Number of Participants With Ischemia Driven TLR (ID-TLR)
Timepoint [51] 0 0
2 years
Secondary outcome [52] 0 0
Number of Participants With Ischemia Driven TLR (ID-TLR)
Timepoint [52] 0 0
3 years
Secondary outcome [53] 0 0
Number of Participants With Ischemia Driven TLR (ID-TLR)
Timepoint [53] 0 0
4 years
Secondary outcome [54] 0 0
Number of Participants With Ischemia Driven TLR (ID-TLR)
Timepoint [54] 0 0
5 years
Secondary outcome [55] 0 0
Number of Participants With Target Vessel Revascularization (TVR)
Timepoint [55] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [56] 0 0
Number of Participants With Target Vessel Revascularization (TVR)
Timepoint [56] 0 0
30 days
Secondary outcome [57] 0 0
Number of Participants With Target Vessel Revascularization (TVR)
Timepoint [57] 0 0
90 days
Secondary outcome [58] 0 0
Number of Participants With Target Vessel Revascularization (TVR)
Timepoint [58] 0 0
180 days
Secondary outcome [59] 0 0
Number of Participants With Target Vessel Revascularization (TVR)
Timepoint [59] 0 0
270 days
Secondary outcome [60] 0 0
Number of Participants With Target Vessel Revascularization (TVR)
Timepoint [60] 0 0
1 year
Secondary outcome [61] 0 0
Number of Participants With Target Vessel Revascularization (TVR)
Timepoint [61] 0 0
2 years
Secondary outcome [62] 0 0
Number of Participants With Target Vessel Revascularization (TVR)
Timepoint [62] 0 0
3 years
Secondary outcome [63] 0 0
Number of Participants With Target Vessel Revascularization (TVR)
Timepoint [63] 0 0
4 years
Secondary outcome [64] 0 0
Number of Participants With Target Vessel Revascularization (TVR)
Timepoint [64] 0 0
5 years
Secondary outcome [65] 0 0
Number of Participants With ID-TVR Excluding TLR
Timepoint [65] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [66] 0 0
Number of Participants With ID-TVR Excluding TLR
Timepoint [66] 0 0
30 days
Secondary outcome [67] 0 0
Number of Participants With ID-TVR Excluding TLR
Timepoint [67] 0 0
90 days
Secondary outcome [68] 0 0
Number of Participants With ID-TVR Excluding TLR
Timepoint [68] 0 0
180 days
Secondary outcome [69] 0 0
Number of Participants With ID-TVR Excluding TLR
Timepoint [69] 0 0
270 days
Secondary outcome [70] 0 0
Number of Participants With ID-TVR Excluding TLR
Timepoint [70] 0 0
1 year
Secondary outcome [71] 0 0
Number of Participants With ID-TVR Excluding TLR
Timepoint [71] 0 0
2 years
Secondary outcome [72] 0 0
Number of Participants With ID-TVR Excluding TLR
Timepoint [72] 0 0
3 years
Secondary outcome [73] 0 0
Number of Participants With ID-TVR Excluding TLR
Timepoint [73] 0 0
4 years
Secondary outcome [74] 0 0
Number of Participants With ID-TVR Excluding TLR
Timepoint [74] 0 0
5 years
Secondary outcome [75] 0 0
Number of Participants With All Coronary Revascularization
Timepoint [75] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [76] 0 0
Number of Participants With All Coronary Revascularization
Timepoint [76] 0 0
30 days
Secondary outcome [77] 0 0
Number of Participants With All Coronary Revascularization
Timepoint [77] 0 0
90 days
Secondary outcome [78] 0 0
Number of Participants With All Coronary Revascularization
Timepoint [78] 0 0
180 days
Secondary outcome [79] 0 0
Number of Participants With All Coronary Revascularization
Timepoint [79] 0 0
270 days
Secondary outcome [80] 0 0
Number of Participants With All Coronary Revascularization
Timepoint [80] 0 0
1 year
Secondary outcome [81] 0 0
Number of Participants With All Coronary Revascularization
Timepoint [81] 0 0
2 years
Secondary outcome [82] 0 0
Number of Participants With All Coronary Revascularization
Timepoint [82] 0 0
3 years
Secondary outcome [83] 0 0
Number of Participants With All Coronary Revascularization
Timepoint [83] 0 0
4 years
Secondary outcome [84] 0 0
Number of Participants With All Coronary Revascularization
Timepoint [84] 0 0
5 years
Secondary outcome [85] 0 0
Number of Participants Experienced All Death/All MI
Timepoint [85] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [86] 0 0
Number of Participants Experienced All Death/All MI
Timepoint [86] 0 0
30 days
Secondary outcome [87] 0 0
Number of Participants Experienced All Death/All MI
Timepoint [87] 0 0
90 days
Secondary outcome [88] 0 0
Number of Participants Experienced All Death/All MI
Timepoint [88] 0 0
180 days
Secondary outcome [89] 0 0
Number of Participants Experienced All Death/All MI
Timepoint [89] 0 0
270 days
Secondary outcome [90] 0 0
Number of Participants Experienced All Death/All MI
Timepoint [90] 0 0
1 year
Secondary outcome [91] 0 0
Number of Participants Experienced All Death/All MI
Timepoint [91] 0 0
2 years
Secondary outcome [92] 0 0
Number of Participants Experienced All Death/All MI
Timepoint [92] 0 0
3 years
Secondary outcome [93] 0 0
Number of Participants Experienced All Death/All MI
Timepoint [93] 0 0
4 years
Secondary outcome [94] 0 0
Number of Participants Experienced All Death/All MI
Timepoint [94] 0 0
5 years
Secondary outcome [95] 0 0
Number of Participants Experienced Cardiac Death/All MI
Timepoint [95] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [96] 0 0
Number of Participants Experienced Cardiac Death/All MI
Timepoint [96] 0 0
30 days
Secondary outcome [97] 0 0
Number of Participants Experienced Cardiac Death/All MI
Timepoint [97] 0 0
90 days
Secondary outcome [98] 0 0
Number of Participants Experienced Cardiac Death/All MI
Timepoint [98] 0 0
180 days
Secondary outcome [99] 0 0
Number of Participants Experienced Cardiac Death/All MI
Timepoint [99] 0 0
270 days
Secondary outcome [100] 0 0
Number of Participants Experienced Cardiac Death/All MI
Timepoint [100] 0 0
1 year
Secondary outcome [101] 0 0
Number of Participants Experienced Cardiac Death/All MI
Timepoint [101] 0 0
2 years
Secondary outcome [102] 0 0
Number of Participants Experienced Cardiac Death/All MI
Timepoint [102] 0 0
3 years
Secondary outcome [103] 0 0
Number of Participants Experienced Cardiac Death/All MI
Timepoint [103] 0 0
4 years
Secondary outcome [104] 0 0
Number of Participants Experienced Cardiac Death/All MI
Timepoint [104] 0 0
5 years
Secondary outcome [105] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Timepoint [105] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [106] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Timepoint [106] 0 0
30 days
Secondary outcome [107] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Timepoint [107] 0 0
90 days
Secondary outcome [108] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Timepoint [108] 0 0
180 days
Secondary outcome [109] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Timepoint [109] 0 0
270 days
Secondary outcome [110] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Timepoint [110] 0 0
1 year
Secondary outcome [111] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Timepoint [111] 0 0
2 years
Secondary outcome [112] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Timepoint [112] 0 0
3 years
Secondary outcome [113] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Timepoint [113] 0 0
4 years
Secondary outcome [114] 0 0
Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)
Timepoint [114] 0 0
5 years
Secondary outcome [115] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Timepoint [115] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [116] 0 0
Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE)
Timepoint [116] 0 0
30 days
Secondary outcome [117] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Timepoint [117] 0 0
90 days
Secondary outcome [118] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Timepoint [118] 0 0
180 days
Secondary outcome [119] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Timepoint [119] 0 0
270 days
Secondary outcome [120] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Timepoint [120] 0 0
1 year
Secondary outcome [121] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Timepoint [121] 0 0
2 years
Secondary outcome [122] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Timepoint [122] 0 0
3 years
Secondary outcome [123] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Timepoint [123] 0 0
4 years
Secondary outcome [124] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)
Timepoint [124] 0 0
5 years
Secondary outcome [125] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF)
Timepoint [125] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [126] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Timepoint [126] 0 0
30 days
Secondary outcome [127] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Timepoint [127] 0 0
90 days
Secondary outcome [128] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Timepoint [128] 0 0
180 days
Secondary outcome [129] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Timepoint [129] 0 0
270 days
Secondary outcome [130] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Timepoint [130] 0 0
1 year
Secondary outcome [131] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Timepoint [131] 0 0
2 years
Secondary outcome [132] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Timepoint [132] 0 0
3 years
Secondary outcome [133] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Timepoint [133] 0 0
4 years
Secondary outcome [134] 0 0
Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)
Timepoint [134] 0 0
5 years
Secondary outcome [135] 0 0
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Timepoint [135] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [136] 0 0
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Timepoint [136] 0 0
30 days
Secondary outcome [137] 0 0
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Timepoint [137] 0 0
90 days
Secondary outcome [138] 0 0
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Timepoint [138] 0 0
180 days
Secondary outcome [139] 0 0
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Timepoint [139] 0 0
270 days
Secondary outcome [140] 0 0
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Timepoint [140] 0 0
1 year
Secondary outcome [141] 0 0
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Timepoint [141] 0 0
2 years
Secondary outcome [142] 0 0
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Timepoint [142] 0 0
3 years
Secondary outcome [143] 0 0
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Timepoint [143] 0 0
4 years
Secondary outcome [144] 0 0
Number of Participants Experienced Death/All MI/All Revascularization (DMR)
Timepoint [144] 0 0
5 years
Secondary outcome [145] 0 0
Number of Participants With Acute Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition)
Timepoint [145] 0 0
0 - 24 hours post stent implantation
Secondary outcome [146] 0 0
Number of Participants With Subacute Scaffold/Stent Thrombosis (Per ARC Definition)
Timepoint [146] 0 0
>24 hours - 30 days post stent implantation
Secondary outcome [147] 0 0
Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)
Timepoint [147] 0 0
30 days - 1 year post stent implantation
Secondary outcome [148] 0 0
Number of Participants With Cumulative Scaffold/Stent Thrombosis (Per ARC Definition)
Timepoint [148] 0 0
0 to 730 Days
Secondary outcome [149] 0 0
Number of Participants With Rehospitalization
Timepoint [149] 0 0
30 days
Secondary outcome [150] 0 0
Number of Participants With Rehospitalization
Timepoint [150] 0 0
90 days
Secondary outcome [151] 0 0
Number of Participants With Rehospitalization
Timepoint [151] 0 0
180 days
Secondary outcome [152] 0 0
Number of Participants With Rehospitalization
Timepoint [152] 0 0
270 days
Secondary outcome [153] 0 0
Number of Participants With Rehospitalization
Timepoint [153] 0 0
1 year
Secondary outcome [154] 0 0
Number of Participants With Rehospitalization
Timepoint [154] 0 0
2 years
Secondary outcome [155] 0 0
Number of Participants With Rehospitalization
Timepoint [155] 0 0
3 years
Secondary outcome [156] 0 0
Number of Participants With Rehospitalization
Timepoint [156] 0 0
4 years
Secondary outcome [157] 0 0
Number of Participants With Rehospitalization
Timepoint [157] 0 0
5 years
Secondary outcome [158] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [158] 0 0
In-hospital (= 7 days post index procedure)
Secondary outcome [159] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [159] 0 0
30 days
Secondary outcome [160] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [160] 0 0
90 days
Secondary outcome [161] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [161] 0 0
180 days
Secondary outcome [162] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [162] 0 0
270 days
Secondary outcome [163] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [163] 0 0
1 year
Secondary outcome [164] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [164] 0 0
2 years
Secondary outcome [165] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [165] 0 0
3 years
Secondary outcome [166] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [166] 0 0
4 years
Secondary outcome [167] 0 0
Number of Participants With Repeat Coronary Arteriography
Timepoint [167] 0 0
5 years
Secondary outcome [168] 0 0
Number of Participants With Target Lesion Failure (TLF)
Timepoint [168] 0 0
1 year

Eligibility
Key inclusion criteria
General

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

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/04/2022
Sample size
Target
Accrual to date
Final
2604
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [6] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Montana
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
New Hampshire
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Oregon
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
Rhode Island
Country [30] 0 0
United States of America
State/province [30] 0 0
South Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
Tennessee
Country [32] 0 0
United States of America
State/province [32] 0 0
Texas
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
Germany
State/province [37] 0 0
Baden-Württemberg
Country [38] 0 0
Germany
State/province [38] 0 0
Bavaria
Country [39] 0 0
Germany
State/province [39] 0 0
Berlin
Country [40] 0 0
Germany
State/province [40] 0 0
Hesse
Country [41] 0 0
Germany
State/province [41] 0 0
Lower Saxony
Country [42] 0 0
Germany
State/province [42] 0 0
North Rhine-Westphalia
Country [43] 0 0
Germany
State/province [43] 0 0
Rhineland-Palatinate
Country [44] 0 0
Germany
State/province [44] 0 0
Schleswig-Holstein
Country [45] 0 0
Singapore
State/province [45] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02173379
Trial related presentations / publications
Stone GW, Ellis SG, Gori T, Metzger DC, Stein B, Erickson M, Torzewski J, Williams J Jr, Lawson W, Broderick TM, Kabour A, Piegari G, Cavendish J, Bertolet B, Choi JW, Marx SO, Genereux P, Kereiakes DJ; ABSORB IV Investigators. Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial. Lancet. 2018 Oct 27;392(10157):1530-1540. doi: 10.1016/S0140-6736(18)32283-9. Epub 2018 Sep 25. Erratum In: Lancet. 2019 Oct 5;394(10205):1230. doi: 10.1016/S0140-6736(19)32175-0.
Public notes

Contacts
Principal investigator
Name 0 0
Gregg W Stone, MD
Address 0 0
Columbia University Medical Center, New York, NY
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02173379