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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
404
Drug-coated stent for coronary arteries
at Hôpital Privé Claude Galien ICPS
Quincy-sous-Sénart, Essonne, France
Triemli Stadtspital
Zurich, Switzerland
MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety)
Incidence
Time frame: at 1 year
clinically driven target lesion revascularization (efficacy)
incidence
Time frame: at 1 year
All-cause mortality
incidence
Time frame: At 1 and 4 months, and 1 and 2 years
Clinically Driven Target Lesion Revascularization
Incidence
Time frame: At 1 and 4 months, and 2 years
Clinically Driven Target Vessel Revascularization
Incidence
Time frame: At 1 and 4 months, and 2 years
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