NCT01977534

To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels

A Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb BVS

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,005 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.

Detailed description

ABSORB UK registry is a prospective, single arm, post-market registry designed to: * Provide ongoing post-market surveillance for documentation of safety and clinical outcomes of the Absorb Everolimus Eluting BVS System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use). * 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.

Conditions

• Coronary Disease
• Coronary Artery Disease
• Coronary Restenosis

Interventions

Type	Name	Description
DEVICE	Absorb BVS	The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating \[formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating\].

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2013-11-06
• Last updated: 2018-12-17

Locations

24 sites across 1 country: United Kingdom