Coronary Artery Disease Clinical Trial
Official title:
ABSORB FIRST Registry: An International Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb Bioresorbable Vascular Scaffold (Absorb BVS).
Verified date | January 2016 |
Source | Abbott Vascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Institutional Review Board |
Study type | Observational [Patient Registry] |
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
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.
Status | Completed |
Enrollment | 1800 |
Est. completion date | December 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | Abbott Vascular International BVBA | Brussels |
Lead Sponsor | Collaborator |
---|---|
Abbott Vascular |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Death (Cardiovascular, Non-Cardiovascular) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | post-procedure | Yes |
Other | Death (Cardiovascular, Non-Cardiovascular) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | 1 year | Yes |
Other | Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | post-procedure | Yes |
Other | MI: QMI and NQMI, TV, and NTV | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | 1 year | Yes |
Other | Target Lesion Revascularization (TLR): all TLR | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | post-procedure | Yes |
Other | TLR: all TLR | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | 1 year | Yes |
Other | TLR: ischemic-driven (ID-TLR) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | post-procedure | Yes |
Other | TLR: ischemic-driven (ID-TLR) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | 1 year | Yes |
Other | Target Vessel Revascularization (TVR): all TVR | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | post procedure | Yes |
Other | TVR: all TVR | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | 1 year | Yes |
Other | TVR: ischemic-driven (ID-TVR) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | post-procedure | Yes |
Other | TVR: ischemic-driven (ID-TVR) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | 1 year | Yes |
Other | All coronary revascularizations (Percutaneous Coronary Intervention (PCI) vs. Coronary Artery Bypass Graft (CABG)) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | post-procedure | Yes |
Other | All coronary revascularizations (PCI vs. CABG) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | 1 year | Yes |
Other | Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | post-procedure | Yes |
Other | Cardiac Death/All MI/ID-TLR (major adverse cardiac event (MACE)) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | post-procedure | Yes |
Other | Cardiac Death/All MI/ID-TLR (MACE) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | 1 year | Yes |
Other | Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | post-procedure | Yes |
Other | Cardiac Death/All MI/ID-TVR (TVF) | Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | 1 year | Yes |
Other | Scaffold/Stent Thrombosis Timing (acute) | Definite, Probable. Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | within 24 hours of index procedure | Yes |
Other | Scaffold/Stent Thrombosis Timing (sub-acute) | Definite, Probable. Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | >24 hours to 30 days | Yes |
Other | Scaffold/Stent Thrombosis Timing (late) | Definite, Probable. Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | >30 days to 1 year | Yes |
Other | Acute Success: Clinical Device Success (lesion level analysis) | Achievement of a final in-scaffold residual diameter stenosis of < 50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | From start of index procedure to end of index procedure. | No |
Other | Acute Success: Clinical Procedure Success (patient based analysis) | Achievement of a final in-scaffold diameter stenosis of < 50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure. Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS. | During the hospital stay with a maximum of 3 days post index procedure. | No |
Primary | Cardiac Death/Target Vessel (TV)-Myocardial Infarction (MI)/Ischemic Driven (ID)-Target Lesion Revascularization (TLR) (Target Lesion Failure (TLF)) | Cardiac Death/TV-MI/ID-TLR at 1 year for the 12 mm or shorter subgroup compared to the 18 mm subgroup. The formal hypothesis is that the safety and performance of the 12 mm or shorter Absorb BVS is similar to the 18 mm Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment). To evaluate this formal hypothesis, the observed Target Lesion Failure (TLF) rates at 1-year will be analyzed by a comparison between the 12 mm or shorter Absorb BVS and 18 mm Absorb BVS subgroups with confidence intervals. The analysis populations will have at least one corresponding size of Absorb BVS implanted but no more than two devices and up to two treated lesions. |
1 year | Yes |
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