Overview

This trial is active, not recruiting.

Condition coronary artery disease
Sponsor Biosensors Europe SA
Start date March 2008
End date September 2012
Trial size 1121 participants
Trial identifier NCT01254487, 07EU01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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

Measure
Primary and secondary stent thrombosis (definite and probable according to ARC definitions)
time frame: 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
time frame: 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
time frame: 30 days, 6 and 12 months, 2, 3 and 5 years
Death and MI
time frame: 30 days, 6 and 12 months, 2, 3 and 5 years
Total revascularization rate (clinically and non clinically driven)
time frame: 30 days, 6 and 12 months, 2, 3 and 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Postmarket Surveillance Registry of the BioMatrix Drug-eluting Stent
Principal investigator Philip Urban, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Biosensors Europe SA.