Prospective, multi-center, open-label single-arm study designed to enroll 370 HBR patients (for at least 340 evaluable) at up to 20 centers in up to 2 European countries. 370 patients will receive a BioFreedomTM CoCr stent. All patients will be followed up for 2 years.
ClinicalTrials.gov ID: NCT03118895
Sponsor
Study objectives
A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding.
CERC Services
- Full Services
Countries
France, Switzerland
Number of investigational sites
2
Number of patients
404
