N/A
Completed N=1,800
ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.
Chronic Total Occlusion of Coronary Artery · Coronary Occlusion · Coronary Artery Disease · Coronary Artery Restenosis
Source: ClinicalTrials.gov NCT01759290 ↗
Enrolled (actual)
1,800
Serious AEs
13.8%
Results posted
Oct 2016
Primary outcomePrimary: Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) — 2.8 percentage of participants
Summary
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to:
* Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
* To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment) for the treatment of patients with ischemic heart disease caused by de novo native coronary artery lesion(s)
* Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) |
2.1 | — |
| SECONDARY Acute Success: Clinical Device Success (Lesion Level Analysis) |
98.0 | — |
| SECONDARY Acute Success: Clinical Procedure Success (Per Subject Analysis) |
97.0 | — |
| SECONDARY Acute Scaffold Thrombosis |
0; 1; 1 | — |
| SECONDARY Subacute ScaffoldThrombosis |
9; 2; 11 | — |
| SECONDARY Late Scaffold Thrombosis |
5; 2; 7 | — |
| SECONDARY All Death, All MI, All Revascularization (DMR) |
8.4 | — |
| SECONDARY Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) |
3.7 | — |
| SECONDARY Major Adverse Cardiac Event (MACE) |
3.1 | — |
| SECONDARY Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) |
2.1 | — |
| SECONDARY Cardiac Death/All MI |
2.1 | — |
| SECONDARY All Death/All MI |
2.3 | — |
| SECONDARY All Death, All MI, All Revascularization (DMR) |
8.4 | — |
| SECONDARY Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) |
3.7 | — |
| SECONDARY Major Adverse Cardiac Event (MACE) |
3.1 | — |
| SECONDARY Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) |
2.1 | — |
| SECONDARY Cardiac Death/All MI |
2.1 | — |
| SECONDARY All Death/All MI |
2.3 | — |
| SECONDARY All Death, All MI, All Revascularization (DMR) |
8.4 | — |
| SECONDARY Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) |
3.7 | — |
| SECONDARY Major Adverse Cardiac Event (MACE) |
3.1 | — |
| SECONDARY Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) |
2.1 | — |
| SECONDARY Cardiac Death/All MI |
2.1 | — |
| SECONDARY All Death/All MI |
2.3 | — |
| SECONDARY All Death, All MI, All Revascularization (DMR) |
8.4 | — |
| SECONDARY Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) |
3.7 | — |
| SECONDARY Major Adverse Cardiac Event (MACE) |
3.1 | — |
| SECONDARY Cardiac Death/All MI |
2.1 | — |
| SECONDARY All Death/All MI |
2.3 | — |
| SECONDARY Death (Cardiovascular, Non-Cardiovascular) |
1.0 | — |
| SECONDARY All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). |
1.4 | — |
| SECONDARY Target Lesion Revascularization (TLR): All TLR |
2.0 | — |
| SECONDARY Target Lesion Revascularization : Ischemia-Driven (ID-TLR) |
1.9 | — |
| SECONDARY Target Vessel Revascularization (TVR): All TVR |
2.9 | — |
| SECONDARY Target Vessel Revascularization : Ischemic-driven (ID-TVR) |
2.6 | — |
| SECONDARY All Revascularization |
7.3 | — |
| SECONDARY Death (Cardiovascular, Non-Cardiovascular) |
1.0 | — |
| SECONDARY All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). |
1.4 | — |
| SECONDARY Target Lesion Revascularization (TLR): All TLR |
2.0 | — |
| SECONDARY Target Lesion Revascularization : Ischemia-Driven (ID-TLR) |
1.9 | — |
| SECONDARY Target Vessel Revascularization (TVR): All TVR |
2.9 | — |
| SECONDARY Target Vessel Revascularization : Ischemic-driven (ID-TVR) |
2.6 | — |
| SECONDARY All Revascularization |
7.3 | — |
| SECONDARY Death (Cardiovascular, Non-Cardiovascular) |
1.0 | — |
| SECONDARY All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). |
1.4 | — |
| SECONDARY Target Lesion Revascularization (TLR): All TLR |
2.0 | — |
| SECONDARY Target Lesion Revascularization : Ischemia-Driven (ID-TLR) |
1.9 | — |
| SECONDARY Target Vessel Revascularization (TVR): All TVR |
2.9 | — |
| SECONDARY Target Vessel Revascularization : Ischemic-driven (ID-TVR) |
2.6 | — |
| SECONDARY All Revascularization |
7.3 | — |
| SECONDARY Death (Cardiovascular, Non-Cardiovascular) |
1.0 | — |
| SECONDARY All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). |
1.4 | — |
| SECONDARY Target Lesion Revascularization (TLR): All TLR |
2.0 | — |
| SECONDARY Target Lesion Revascularization : Ischemia-Driven (ID-TLR) |
1.9 | — |
| SECONDARY Target Vessel Revascularization (TVR): All TVR |
2.9 | — |
| SECONDARY Target Vessel Revascularization : Ischemic-driven (ID-TVR) |
2.6 | — |
| SECONDARY All Revascularization |
7.3 | — |
Eligibility Criteria
Inclusion Criteria
- The inclusion criteria must follow the most recent IFU which may include but are not limited to the following:
- Patient must be at least 18 years of age at the time of signing the Informed Consent Form
- Patient is to be treated for de novo lesions located in previously untreated vessels.
- Patient must agree to undergo all required follow-up visits and data collection.
Exclusion Criteria
- The exclusion criteria must follow the most recent IFU which may include but are not limited to the following:
- Inability to obtain a signed informed consent from potential patient.
- Patient belongs to a vulnerable population (per investigator's judgment, this also includes people with a direct link (hierarchical or financial benefit) to the registry Doctor or the registry Sponsor).
Data sourced from ClinicalTrials.gov (NCT01759290). 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.