LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
Recruiting now · Not applicable
Conditions studied: Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia, Acute Coronary Syndrome
In brief
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.
Key facts
- Study ID
- NCT06657326
- Run by
- Biosensors Europe SA
- People needed
- 444
- Starts
- 2024-12-18
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2025-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients at high bleeding risk (HBR) with an indication for PCI who can tolerate at least one month of DAPT. This includes patients with stable angina, silent ischemia, acute coronary syndromes (ACS) (STEMI and NSTEMI), de novo lesions in native arteries with diameter stenosis >70% by visual estimation and evidence of ischemia in the territory of the target vessel(s).
- Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.
You may not qualify if…
- Pregnant and breastfeeding women
- Age <18 years old
- Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
- Patients expected not to comply with 1 month DAPT
- Active bleeding at the time of inclusion
- Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only)
- Number of target lesions >2
- Patient requires a stent of diameter <2.25mm
- Patient requires a stent of diameter >4.0mm
- Isolated ostial lesions within 3 mm of the origin of LAD or LCx (left main lesions involving the ostia of the LAD and/or LCx are eligible)
- Patient has known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary)
- Patient with chronic total occlusion(s) as target lesion(s)
- Severe calcification that might prevent sufficient expansion of the DES, unless pre-treated with a plaque modification device such as cutting balloon, scoring balloon or intravascular lithotripsy.
- Note: Use of rotational or orbital atherectomy is also permitted.
- Cardiogenic shock
- Compliance with long-term single anti-platelet therapy unlikely
- Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated
- Any PCI during the previous 12 months
- Participation in another clinical study (12 months after index procedure)
- Patients with a life expectancy of <12 months
Where it is running
- Hospital Sultanah Aminah — Johor Bahru, Johor, Malaysia (enrolling)
- Hospital Tengku Ampuan Afzan — Kuantan, Pahang, Malaysia (enrolling)
- Hospital Raja Permaisuri Bainun — Ipoh, Perak, Malaysia (enrolling)
- Hospital Queen Elizabeth II — Kota Kinabalu, Sabah, Malaysia (enrolling)
- Pusat Jantung Hospital Umum Sarawak — Kota Kinabalu, Sarawak, Malaysia (enrolling)
- Hospital Serdang — Kajang, Selangor, Malaysia (enrolling)
Full record on ClinicalTrials.gov
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