Status:
COMPLETED
e-BioMatrix PostMarket Surveillance Registry
Lead Sponsor:
Biosensors Europe SA
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
1121 Patients enrolled
Trial Details
Trial ID
NCT01254487
Start Date
March 1 2008
End Date
September 1 2014
Last Update
May 6 2019
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Arrixaca University Hospital
Murcia, Spain, 30120
2
Inselspital
Bern, Switzerland, 3010
3
Hôpital Cantonal de Fribourg
Fribourg, Switzerland, 1708
4
Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1211