e-BioMatrix PostMarket Registry

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01289002
• Lead Sponsor: Biosensors Europe SA

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• 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: 5652

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE	12 months	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 at 12 months.

Secondary Outcome Measures

Name	Time	Method
MACE	30 days, 6 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 at 30 days, 6 months, 2, 3 and 5 years;
Death and MI at 30 days, 6 and 12 months, 2, 3 and 5 years;	30 days, 6 and 12 months, 2, 3 and 5 years;
stent thrombosis	30 days, 6 and 12 months, 2, 3 and 5 years	Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 30 days, 6 and 12 months, 2, 3 and 5 years;
Total revascularization rate (clinically and non clinically driven) at 30 days, 6 and 12 months, 2, 3 and 5 years.	30 days, 6 and 12 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 at 30 days, 6 and 12 months, 2, 3 and 5 years;	6 and 12 months, 2, 3 and 5 years
Death and post-procedural MI at 30 days, 6 and 12 months, 2, 3 and 5 years;	30 days, 6 and 12 months, 2, 3 and 5 years

Trial Locations

Locations (69)

Universität Innsbruck; 🇦🇹 Innsbruck, Austria

AKH der Stadt Wien; 🇦🇹 Vienna, Austria

KFJ - Hospital Vienna; 🇦🇹 Vienna, Austria

Krankenanstalt Rudolfstiftung; 🇦🇹 Vienna, Austria

Teaching Hospital Brno; 🇨🇿 Brno, Czechia

Masaryk Hospital Usti nad Labem; 🇨🇿 Usti nad Labem, Czechia

Roskilde Sygehus; 🇩🇰 Roskilde, Denmark

Clinique Rhône Durance; 🇫🇷 Avignon, France

Hopital de la Cavale Blanche; 🇫🇷 Brest, France

Hôpital Cardiovasculaire et Pneumologique Louis Pradel; 🇫🇷 Bron, France

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