A post-market surveillance registry of the BioMatrix coronary stent
Phase 4
Completed
- Conditions
- Health Condition 1: null- Coronary Artery Occlusion
- Registration Number
- CTRI/2012/05/002657
- Lead Sponsor
- Biosensors Europe SA Moges Switzerland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4000
Inclusion Criteria
1. Patients that need a treatment with a BioMatrix drug-eluting stent;
2. 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;
3. 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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method