Overview

This trial is active, not recruiting.

Condition coronary artery disease
Sponsor Biosensors Europe SA
Start date April 2008
End date September 2012
Trial size 4000 participants
Trial identifier NCT01289002, 07EU02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
MACE
time frame: 12 months

Secondary Outcomes

Measure
stent thrombosis
time frame: 30 days, 6 and 12 months, 2, 3 and 5 years
MACE
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 at 30 days, 6 and 12 months, 2, 3 and 5 years;
time frame: 6 and 12 months, 2, 3 and 5 years
Death and MI at 30 days, 6 and 12 months, 2, 3 and 5 years;
time frame: 30 days, 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;
time frame: 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.
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 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

Additional Information

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