e-BioMatrix PostMarket Surveillance Registry

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01254487
• Lead Sponsor: Biosensors Europe SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Primary Completion: 2012-09
• Study Completion: 2014-09
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1121

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization	12 Months

Secondary Outcome Measures

Name	Time	Method
Primary and secondary stent thrombosis (definite and probable according to ARC definitions)	30 days, 6 and 12 months, 2, 3 and 5 years
Major adverse cardiac events (MACE) in the overall population, defined as composite of cardiac death, myocardial infarction (Q-wave and non-Q-wave), or justified target vessel revascularization	30 days, 6 months, 2, 3 and 5 years
Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any clinically driven target vessel revascularization	30 days, 6 and 12 months, 2, 3 and 5 years
Total revascularization rate (clinically and non clinically driven)	30 days, 6 and 12 months, 2, 3 and 5 years
Death and MI	30 days, 6 and 12 months, 2, 3 and 5 years

Trial Locations

Locations (9)

Cardiocentro Ticino; 🇨🇭 Lugano, Switzerland

Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland

Triemli Hospital; 🇨🇭 Zürich, Switzerland

Brighton-Sussex University Hospitals; 🇬🇧 Brighton, United Kingdom

Arrixaca University Hospital; 🇪🇸 Murcia, Spain

Inselspital; 🇨🇭 Bern, Switzerland

Hôpital Cantonal de Fribourg; 🇨🇭 Fribourg, Switzerland

Hôpital de La Tour; 🇨🇭 Meyrin, Switzerland

Manchester Heart Center; 🇬🇧 Manchester, United Kingdom