e-BioMatrix Canada Registry

Launched by BIOSENSORS EUROPE SA · Aug 2, 2013

Keywords

ClinConnect Summary

The purpose of this registry is to capture additional "on-label" clinical data of the CE-marked BioMatrix Flex™ (BA9™-Eluting) stent system in relation to safety and effectiveness.

This prospective, multi-center registry will enroll a total of 533 patients. The BioMatrix FlexTM has been studied in randomized controlled trials and has been granted the CE mark. The data have been reviewed by Health Canada and no further randomized trials were requested. Prior to marketing approval, Health Canada requested that a registry be implemented to provide data in Canada on 'on label patients' to supp...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years
• • 2. Presence of coronary artery stenosis in one or two native coronary arteries from 2.25 to 4.0 mm in diameter that can be each covered with one BioMatrix FlexTM stent
• • 3. Up to two lesions in two separate vessels to be treated
• Exclusion Criteria:
• • 1. Inability to provide informed consent;
• • 2. Life expectancy less than 2 years;
• • 3. Staged procedure planned within index procedure hospitalization;
• • 4. ST elevation myocardial infarction;
• • 5. Angiographic evidence of thrombus;
• • 6. EF \< 20%;
• • 7. Coronary artery bypass graft-lesion incl SVG;
• • 8. Chronic total occlusion of the target lesion;
• • 9. In stent restenosis
• • 10. Bifurcation requiring 2 or more stents;
• • 11. Left Main lesion;
• • 12. Renal insufficiency (serum creatinine \> 260 µmolmol/L or \> 2.95mg/dl)
• • 13. Multi-vessel disease with more than two vessels affected;
• • 14. Have known intolerance to aspirin, clopidogrel, heparin, stainless steel, Biolimus A9 (limus compounds), contrast material;
• • 15. Currently participating in another study;
• • 16. Planning to have surgery within 6 months (excluding surgery which DAPT is maintained throughout the peri-surgical period);
• • 17. Woman of childbearing potential with a positive pregnancy test.