NCT06657326 LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
| NCT ID | NCT06657326 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biosensors Europe SA |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 444 participants |
| Start Date | 2024-12-18 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 444 participants in total. It began in 2024-12-18 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Kamaraj a/l Selvaraj, Dr.
PRINCIPAL INVESTIGATOR
Hospital Serdang
Frequently Asked Questions
Who can join the NCT06657326 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06657326 currently recruiting?
Yes, NCT06657326 is actively recruiting participants. Contact the research team at ki.ang@biosensors.com for enrollment information.
Where is the NCT06657326 trial being conducted?
This trial is being conducted at Johor Bahru, Malaysia, Kuantan, Malaysia, Ipoh, Malaysia, Kota Kinabalu, Malaysia and 2 additional locations.
Who is sponsoring the NCT06657326 clinical trial?
NCT06657326 is sponsored by Biosensors Europe SA. The principal investigator is Kamaraj a/l Selvaraj, Dr. at Hospital Serdang. The trial plans to enroll 444 participants.