NCT03118895

Leaders Free III: BioFreedom™ Clinical Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Cardiac Death
• Myocardial Infarction
• Stent Thrombosis
• Bleeding
• Mortality

Interventions

Type	Name	Description
DEVICE	BioFreedom™ BA9™ drug-coated stent	Drug-coated stent for coronary arteries

Timeline

• Start date: 2017-11-08
• Primary completion: 2019-09-05
• Completion: 2022-11-18
• First posted: 2017-04-18
• Last updated: 2024-02-29

Locations

2 sites across 2 countries: France, Switzerland