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 (ABSORB UK)

Abbott

Status: Completed

Conditions: Coronary Artery Disease; Coronary Restenosis; Coronary Disease

Treatments: Device: Absorb BVS

Study type: Observational

Funder types: Industry

Identifiers

NCT01977534

13-304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,005 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

1,005 participants in 1 patient group

Absorb BVS

Description:

Subjects receiving Absorb BVS

Treatment:

Device: Absorb BVS