eULTRA 10 K
Biosensors Europe S.A.
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.
The hypothesis is that the observed Target Lesion Failure (TLF) rate is noninferior compared to performance goal of 7.8%.
- Primary endpoint is Target Lesion Failure (TLF) at 12 months according to ARC-2 definition.
Clinical event management,
Central data monitoring,
Europe (France, Spain, Portugal, Germany, Austria), Ireland, UK, Switzerland, Maghreb (Tunisia, Algeria) and Macedonia
Number of centres: In progress (around 100)
Number of planned patients: 10 000