A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding
Study Details | NCT02843633 | LEADERS FREE II: BioFreedom™ Pivotal Study | ClinicalTrials.gov
Sponsor
Study objectives
This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.
Primary endpoints
- Safety:
The composite of cardiac death and myocardial infarction at 1 year
- Efficacy:
The incidence of clinically driven target lesion revascularization at 1 year
CERC Services
- CEC activities
- Monitoring activities
- Core Laboratory
- Regulatory submissions
Countries
7 : France (FR), United Kingdom (UK), Germany (DE), Italy (IT) Denmark (DK), Canada (CA), United States of America (USA)
Number of investigational sites
85 European and North American sites. CERC is responsible for the European sites. These are distributed by 5 countries: France, Denmark, Germany, UK and Italy.
Number of patients
1203
