Skip to content

LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients

RecruitingNot applicableNCT06657326
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Conditions
Interventions
  • Device: BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent
  • Device: BioFreedom™ stainless steel Biolimus A9™-coated stent
Sponsor
Biosensors Europe SA
Start date
2024-12-18
Primary completion
2026-08
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Malaysia
Total sites listed
6

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. 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). 2. Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria. Exclusion Criteria: 1. Pregnant and breastfeeding women 2. Age \<18 years old 3. Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent 4. Patients expected not to comply with 1 month DAPT 5. Active bleeding at the time of inclusion 6. Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only) 7. Number of target lesions \>2 8. Patient requires a stent of diameter \<2.25mm 9. Patient requires a stent of diameter \>4.0mm 10. 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) 11. 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) 12. Patient with chronic total occlusion(s) as target lesion(s) 13. 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. 14. Cardiogenic shock 15. Compliance with long-term single anti-platelet therapy unlikely 16. 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 17. Any PCI during the previous 12 months 18. Participation in another clinical study (12 months after index procedure) 19. Patients with a life expectancy of \<12 months

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06657326