Biosensors Europe S.A.

Brief summary

eUltra 10k is a post market, prospective, observational, multicenter registry aimed at evaluating the non-inferiority of BioFreedom^TM Ultra CoCr Biolimus A9 (BA9)^TM coated coronary stent in patient with coronary artery disease treated by Percutaneous Coronary Intervention.

Study Hypothesis

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

Set-up activities,

Regulatory submission,

Monitoring,

Clinical event management,

eCRF/data management,

Data processing,

Central data monitoring,

Statistical analysis

Countries

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