NCT01759290

ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.

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).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,800 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

the ABSORB FIRST Registry is intended to provide an assessment of the safety and performance of the Absorb BVS device in accordance to the IFU in real world use involving more complex patients, lesions and use (examples: longer lesions, overlapping use, bailout, patients at high risks for cardiac events, etc.). The ABSORB FIRST study will register a minimum of 1800 patients in approximately 90 sites throughout multiple countries worldwide where Absorb BVS has regulatory approval or is commercially available.

Conditions

• Chronic Total Occlusion of Coronary Artery
• Coronary Occlusion
• Coronary Artery Disease
• Coronary Artery Restenosis
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Restenosis

Interventions

Type	Name	Description
DEVICE	Absorb Bioresorbable Vascular Scaffold	Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2013-01-03
• Last updated: 2016-10-19
• Results posted: 2016-10-19

Locations

1 site across 1 country: Belgium