N/A
Completed N=459
A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)
Coronary Artery Disease · Coronary Artery Stenosis · Coronary Disease · Coronary Stenosis
Source: ClinicalTrials.gov NCT01923740 ↗
Enrolled (actual)
459
Serious AEs
38.1%
Results posted
Feb 2018
Primary outcomePrimary: In-segment Late Loss (LL) - Per Subject Analysis — 0.19; 0.13 Millimeter
Summary
To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In-segment Late Loss (LL) - Per Subject Analysis |
0.19; 0.13 | — |
| PRIMARY In-segment Late Loss (LL) - Per Lesion Analysis |
0.19; 0.13 | — |
| SECONDARY Acute Device Success |
98.0; 99.6 | — |
| SECONDARY Number of Participants With Acute Procedural Success |
230; 230 | — |
| SECONDARY Number of Death (Cardiac, Vascular, Non-cardiovascular) |
6; 7 | — |
| SECONDARY Number of Death (Cardiac, Vascular, Non-cardiovascular) |
6; 7 | — |
| SECONDARY Number of Death (Cardiac, Vascular, Non-cardiovascular) |
6; 7 | — |
| SECONDARY Number of Death (Cardiac, Vascular, Non-cardiovascular) |
6; 7 | — |
| SECONDARY Number of Death (Cardiac, Vascular, Non-cardiovascular) |
6; 7 | — |
| SECONDARY Number of Death (Cardiac, Vascular, Non-cardiovascular) |
6; 7 | — |
| SECONDARY Number of Death (Cardiac, Vascular, Non-cardiovascular) |
6; 7 | — |
| SECONDARY Number of Death (Cardiac, Vascular, Non-cardiovascular) |
6; 7 | — |
| SECONDARY Number of Death (Cardiac, Vascular, Non-cardiovascular) |
6; 7 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
7; 6 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
7; 6 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
7; 6 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
7; 6 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
7; 6 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
7; 6 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
7; 6 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
7; 6 | — |
| SECONDARY Number of Participants With Myocardial Infarction |
7; 6 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
12; 9 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
12; 9 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
12; 9 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
12; 9 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
12; 9 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
12; 9 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
12; 9 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
12; 9 | — |
| SECONDARY Number of Participants With Target Lesion Revascularization (TLR) |
12; 9 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TVR) |
16; 16 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TVR) |
16; 16 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TVR) |
16; 16 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TVR) |
16; 16 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TVR) |
16; 16 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TVR) |
16; 16 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TVR) |
16; 16 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TVR) |
16; 16 | — |
| SECONDARY Number of Participants With Target Vessel Revascularization (TVR) |
16; 16 | — |
| SECONDARY Number of Participants With All Coronary Revascularization (PCI and CABG) |
28; 26 | — |
| SECONDARY Number of Participants With All Coronary Revascularization (PCI and CABG) |
28; 26 | — |
| SECONDARY Number of Participants With All Coronary Revascularization (PCI and CABG) |
28; 26 | — |
| SECONDARY Number of Participants With All Coronary Revascularization (PCI and CABG) |
28; 26 | — |
| SECONDARY Number of Participants With All Coronary Revascularization (PCI and CABG) |
28; 26 | — |
| SECONDARY Number of Participants With All Coronary Revascularization (PCI and CABG) |
28; 26 | — |
| SECONDARY Number of Participants With All Coronary Revascularization (PCI and CABG) |
28; 26 | — |
| SECONDARY Number of Participants With All Coronary Revascularization (PCI and CABG) |
28; 26 | — |
| SECONDARY Number of Participants With All Coronary Revascularization (PCI and CABG) |
28; 26 | — |
| SECONDARY Number of Death/All MI |
13; 10 | — |
| SECONDARY Number of Death/All MI |
13; 10 | — |
| SECONDARY Number of Death/All MI |
13; 10 | — |
| SECONDARY Number of Death/All MI |
13; 10 | — |
| SECONDARY Number of Death/All MI |
13; 10 | — |
| SECONDARY Number of Death/All MI |
13; 10 | — |
| SECONDARY Number of Death/All MI |
13; 10 | — |
| SECONDARY Number of Death/All MI |
13; 10 | — |
| SECONDARY Number of Death/All MI |
13; 10 | — |
| SECONDARY Number of Cardiac Death/All MI |
10; 6 | — |
| SECONDARY Number of Cardiac Death/All MI |
10; 6 | — |
| SECONDARY Number of Cardiac Death/All MI |
10; 6 | — |
| SECONDARY Number of Cardiac Death/All MI |
10; 6 | — |
| SECONDARY Number of Cardiac Death/All MI |
10; 6 | — |
| SECONDARY Number of Cardiac Death/All MI |
10; 6 | — |
| SECONDARY Number of Cardiac Death/All MI |
10; 6 | — |
| SECONDARY Number of Cardiac Death/All MI |
10; 6 | — |
| SECONDARY Number of Cardiac Death/All MI |
10; 6 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
34; 34 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
34; 34 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
34; 34 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
34; 34 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
34; 34 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
34; 34 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
34; 34 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
34; 34 | — |
| SECONDARY Number of Participants With All Death/All MI/All Revascularization (DMR) |
34; 34 | — |
| SECONDARY Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] |
16; 12 | — |
| SECONDARY Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] |
16; 12 | — |
| SECONDARY Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] |
16; 12 | — |
| SECONDARY Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] |
16; 12 | — |
| SECONDARY Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] |
16; 12 | — |
| SECONDARY Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] |
16; 12 | — |
| SECONDARY Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] |
16; 12 | — |
| SECONDARY Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] |
16; 12 | — |
| SECONDARY Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)] |
16; 12 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] |
19; 19 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] |
19; 19 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] |
19; 19 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] |
19; 19 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] |
19; 19 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] |
19; 19 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] |
19; 19 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] |
19; 19 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)] |
19; 19 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) |
17; 13 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) |
17; 13 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) |
17; 13 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) |
17; 13 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) |
17; 13 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) |
17; 13 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) |
17; 13 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) |
17; 13 | — |
| SECONDARY Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE]) |
17; 13 | — |
| SECONDARY Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition) |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition) |
0; 0; 1; 0 | — |
| SECONDARY Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition) |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition) |
1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition) |
1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition) |
0; 0; 1; 1 | — |
| SECONDARY Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition) |
0; 0; 1; 1 | — |
| SECONDARY Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis |
1; 0; 2; 1 | — |
| SECONDARY In-Device Minimum Lumen Diameter (MLD) |
2.24; 2.50 | — |
| SECONDARY In-Segment Minimum Lumen Diameter (MLD) |
2.11; 2.17 | — |
| SECONDARY Proximal Minimum Lumen Diameter (MLD) |
2.64; 2.68 | — |
| SECONDARY Distal Minimum Lumen Diameter (MLD) |
2.39; 2.37 | — |
| SECONDARY In-Segment Percent Diameter Stenosis (%DS) |
24.02; 22.96 | — |
| SECONDARY In-Device Percent Diameter Stenosis (%DS) |
19.16; 11.15 | — |
| SECONDARY Proximal Percent Diameter Stenosis (%DS) |
11.09; 12.12 | — |
| SECONDARY Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR) |
1.0; 1.5 | — |
| SECONDARY Distal Percent Diameter Stenosis (%DS) |
8.53; 8.14 | — |
| SECONDARY Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR) |
4.2; 2.9 | — |
| SECONDARY Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR) |
3.3; 1.0 | — |
| SECONDARY In-Segment Late Loss (LL) |
0.19; 0.13 | — |
| SECONDARY Percentage of Participants With Distal Angiographic Binary Restenosis (ABR) |
0.0; 1.0 | — |
| SECONDARY In-Device Late Loss (LL) |
0.24; 0.10 | — |
| SECONDARY Proximal Late Loss (LL) |
0.19; 0.13 | — |
| SECONDARY Distal Late Loss (LL) |
0.08; 0.03 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must be at least 18 years of age at the time of signing the informed consent form.
- Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure.
- Subject must have evidence of myocardial ischemia (e.g., stable angina, unstable angina, post-infarct angina or silent ischemia) suitable for elective percutaneous coronary intervention (PCI). Subjects with stable angina or silent ischemia and 700,000 cells/mm3.
- Subject has a known or documented hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
- Subject has known renal insufficiency as defined as an estimated glomerular filtration rate (eGFR) 5 minutes.
- No ST depression or elevation lasting > 5 minutes.
Data sourced from ClinicalTrials.gov (NCT01923740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.