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.
ClinicalTrials.gov ID: NCT05505929
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)
