LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
brief summary
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.
detailed description
The LEADERS FREE IV trial is conducted to evaluate of the efficacy (QCA) and safety of the BioFreedom™ Ultra Drug Coated Stent in patients with High Bleeding Risk (HBR) and coronary artery disease undergoing Percutaneous Coronary Intervention.
It is a prospective, multi-center, single blind (to patient), randomized, comparator trial, designed to randomize 444 HBR patients at approximately up to 7 centers in Malaysia.
The primary objective is to confirm non-inferiority of the BioFreedom™ Ultra stent compared to BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at 9 months, and the main secondary objective is to assess safety as measured by TLF and ST. 444 patients will be randomized 1:1 to either stent, allowing for a direct comparison, and will be followed up to 5 years to measure for late TLF and ST events.
official title
Evaluation of the Efficacy (QCA) and Safety of the BioFreedom™ Ultra Drug Coated Stent in Patients With High Bleeding Risk and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention