eUltra 10k is a post market, prospective, observational, multicenter registry aimed at evaluating the non-inferiority of BioFreedomTM Ultra CoCr Biolimus A9 (BA9)TM coated coronary stent in patient with coronary artery disease treated by Percutaneous Coronary Intervention.
Sponsor
Study objectives
The hypothesis is that the observed Target Lesion Failure (TLF) rate is noninferior compared to performance goal of 7.8%.
Primary endpoints
- Primary endpoint is Target Lesion Failure (TLF) at 12 months according to ARC-2 definition.
CERC Services
- Central data monitoring
- CRF and Data management
- Data processing - Newsletter
- Monitoring activities
- Regulatory submissions
- Set-up activities, e-consent
- Statistical Analysis
Countries
Europe (France, Spain, Germany, Austria), UK, Switzerland, Tunisia, UAE, Lithuania
Number of investigational sites
70
Number of patients
10.000 (planned patients)
