A Postmarket Surveillance Registry of the BioMatrix Drug-eluting Stent

Biosensors Europe SA9 sites in 3 countries1,121 target enrollmentMarch 2008

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Biosensors Europe SA
Enrollment: 1121
Locations: 9
Primary Endpoint: 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
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 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 a BioMatrix™ 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 BioMatrix™ type
•Patients receiving next to the BioMatrix™ stent also other coronary vascular interventions, for example dilation.

Outcomes

Primary Outcomes

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

Time Frame: 12 Months

Secondary Outcomes

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)