A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.

Biosensors Europe SA69 sites in 16 countries5,652 target enrollmentApril 2008

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Biosensors Europe SA
Enrollment: 5652
Locations: 69
Primary Endpoint: MACE
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

September 2014

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Biosensors Europe SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years
•Patients that need a treatment with either a BioMatrix™ or a BioMatrix Flex™ drug-eluting stent
•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
•No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria

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

Outcomes

Primary Outcomes

MACE

Time Frame: 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 Outcomes

MACE(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)
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)