e-BioMatrix PostMarket Registry (eBMX-PMR)

Biosensors International

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01289002

07EU02

Details and patient eligibility

About

The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.

Full description

Prospective, multi-center registry to be conducted at 60-70 international interventional cardiology centers. All patients will be followed for up to 3 years.

Enrollment: 5,652 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years
2. Patients that need a treatment with either a BioMatrix™ or a BioMatrix Flex™ drug-eluting stent
3. Presence of one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents
4. No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion criteria

1. Inability to provide informed consent
2. Patients needing additional stent NOT of the Biolimus A9™-eluting stent type
3. Patients receiving next to the Biolimus A9™-eluting stent also other coronary vascular interventions, for example dilation
4. Patients receiving both the BioMatrix™ and the BioMatrix Flex™ stent during index and/or staged procedure