CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,800 enrolled
Drug / intervention
Absorb Bioresorbable Vascular Scaffolddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01759290
NCT01759290N/ACompleted

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).

Abbott Medical Devices·observational·Posted Jan 3, 2013·Updated Oct 19, 2016

In Brief

An observational study evaluating Absorb Bioresorbable Vascular Scaffold for Chronic Total Occlusion of Coronary Artery and 6 related conditions. Completed, enrolled 1,800 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 3, 2013
Enrollment StartJan 1, 2013
Primary CompletionAug 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 13.5 years ago

Interventions

Absorb Bioresorbable Vascular Scaffolddevice

Subjects receiving the Absorb Bioresorbable Vascular Scaffold