Status: Recruiting
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™ DCS.
Participants needed: 444
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Biosensors Europe SAUpdated: Jun 5, 2025Locations: 6
Eligibility criteria
Patients at high bleeding risk (HBR) with an indication for PCI who can tolerate... [+1]
Pregnant and breastfeeding women [+18]