LEADERS FREE II: BioFreedom™ Pivotal Study

Summary

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.

Timeline

Start

2017-02-14

Primary completion

2018-10-11

Completion

2021-03

Publications

• Eberli FR, Oldroyd KG, Urban P, Krucoff MW, Morice MC, Tanguay JF, Leon MB, Brunel P, Maillard L, Lipiecki J, Cook S, Berland J, Hovasse T, Carrie D, Schutte D, Sadozai Slama S, Garot P. Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years. Open Heart. 2024 Jun 18;11(1):e002679. doi: 10.1136/openhrt-2024-002679.
• Campos CM, Mehran R, Capodanno D, Owen R, Windecker S, Varenne O, Stone GW, Valgimigli M, Hajjar LA, Kalil Filho R, Oldroyd K, Morice MC, Urban P, Abizaid A. Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials. Circ Cardiovasc Interv. 2024 Apr;17(4):e013000. doi: 10.1161/CIRCINTERVENTIONS.122.013000. Epub 2024 Apr 16.
• Mehran R, Chandrasekhar J, Urban P, Lang IM, Windhoevel U, Spaulding C, Copt S, Stoll HP, Morice MC; LEADERS FREE Investigators. Sex-Based Outcomes in Patients With a High Bleeding Risk After Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy: A Secondary Analysis of the LEADERS FREE Randomized Clinical Trial. JAMA Cardiol. 2020 Aug 1;5(8):939-947. doi: 10.1001/jamacardio.2020.0285.

Drugs

Indications