LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
NCT ID: NCT06657326
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
444 participants
INTERVENTIONAL
2024-12-18
2030-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
BioFreedom QCA Study in CAD Patients
NCT03307213
A Randomized Clinical Evaluation of the BioFreedom™ Stent
NCT01623180
Asian Registry of the BioFreedom Stent for STEMI Patients
NCT03609346
BioFreedom FIM Clinical Trial.
NCT01172119
A Study Evaluating the Vascular Healing and Neointimal Transformation at 1 Month After Implantation of BioFreedom™ Drug-coated Stents and the Xience Drug-eluting Stent System in Patients With Acute Coronary Syndrome and High Bleeding Risk Using Optical Coherence Tomography
NCT07230847
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
It is a prospective, multi-center, single blind (to patient), randomized, comparator trial, designed to randomize 444 HBR patients at approximately up to 7 centers in Malaysia.
The primary objective is to confirm non-inferiority of the BioFreedom™ Ultra stent compared to BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at 9 months, and the main secondary objective is to assess safety as measured by TLF and ST. 444 patients will be randomized 1:1 to either stent, allowing for a direct comparison, and will be followed up to 5 years to measure for late TLF and ST events.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BioFreedom™ Ultra DCS
Coronary artery disease patients with high-bleeding risk (HBR) will receive the BioFreedom™ Ultra stent if randomized to this arm (1:1 ratio)
BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent
Stent implantation
BioFreedom™ DCS
Coronary artery disease patients with high-bleeding risk (HBR) will receive the BioFreedom™ stent if randomized to this arm (1:1 ratio)
BioFreedom™ stainless steel Biolimus A9™-coated stent
Stent implantation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent
Stent implantation
BioFreedom™ stainless steel Biolimus A9™-coated stent
Stent implantation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biosensors Europe SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kamaraj a/l Selvaraj, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Serdang
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Sultanah Aminah
Johor Bahru, Johor, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
Hospital Queen Elizabeth II
Kota Kinabalu, Sabah, Malaysia
Pusat Jantung Hospital Umum Sarawak
Kota Kinabalu, Sarawak, Malaysia
Hospital Serdang
Kajang, Selangor, Malaysia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24-AP-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.