e-BioMatrix PostMarket Surveillance Registry

Biosensors International

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01254487

07EU01

Details and patient eligibility

About

The purpose of the e-BioMatrix PMS registry is to capture clinical data of the BioMatrix (Biolimus A9-Eluting) stent system in relation to safety and effectiveness.

Enrollment: 1,121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years
2. Patients that need a treatment with a BioMatrix™ 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 BioMatrix™ type
3. Patients receiving next to the BioMatrix™ stent also other coronary vascular interventions, for example dilation.