Compares two drug-coated stents in people with coronary artery disease and high bleeding risk
Tests a newer drug-coated stent against an older one in adults with coronary artery disease.
Plain-language title generated from the registry record
Registry title: LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
Key facts
- Where
- Ipoh, Johor Bahru, Kajang, Kota Kinabalu, and Kuantan, MalaysiaSee the 6 sites
Where in Malaysia
- Hospital Raja Permaisuri BainunIpoh, MalaysiaTaking people
- Hospital Sultanah AminahJohor Bahru, MalaysiaTaking people
- Hospital SerdangKajang, MalaysiaTaking people
- Hospital Queen Elizabeth IIKota Kinabalu, MalaysiaTaking people
- Pusat Jantung Hospital Umum SarawakKota Kinabalu, MalaysiaTaking people
- Hospital Tengku Ampuan AfzanKuantan, MalaysiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biosensors Europe SA
- Trial code
- NCT06657326
- Record updated
- 5 June 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; Any PCI during the previous 12 months; Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent; Active bleeding at the time of inclusion; 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; 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); Compliance with long-term single anti-platelet therapy unlikely; Age <18 years old; Pregnant and breastfeeding women; Patients expected not to comply with 1 month DAPT; 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 with chronic total occlusion(s) as target lesion(s); Cardiogenic shock; Participation in another clinical study (12 months after index procedure); Patients with a life expectancy of <12 months.