Actively Recruiting
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
Led by Biosensors Europe SA · Updated on 2025-06-05
444
Participants Needed
6
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients at high bleeding risk (HBR) with indication for PCI who can tolerate at least one month of dual antiplatelet therapy (DAPT), including those with stable angina, silent ischemia, or acute coronary syndromes (STEMI and NSTEMI)
- Patients with de novo lesions in native arteries having diameter stenosis greater than 70% by visual estimation and evidence of ischemia in the target vessel territory
- Patients meeting the ARC-HBR definition with at least 1 major or 2 minor criteria
You will not qualify if you...
- Pregnant and breastfeeding women
- Age under 18 years
- Patients lacking capacity to provide informed consent (e.g., dementia)
- Patients unlikely to comply with one month of DAPT
- Active bleeding at the time of inclusion
- Procedures requiring non-study stents or therapeutic options not followed by stent implantation
- More than 2 target lesions
- Need for stent diameter less than 2.25 mm or greater than 4.0 mm
- Isolated ostial lesions within 3 mm of the origin of LAD or LCx (except left main lesions involving these ostia)
- Known left ventricular ejection fraction less than 30%
- Chronic total occlusion as target lesion(s)
- Severe calcification preventing stent expansion unless pre-treated with plaque modification device
- Cardiogenic shock
- Unlikely compliance with long-term single antiplatelet therapy
- Known hypersensitivity or contraindications to aspirin, clopidogrel or other P2Y12 inhibitors, cobalt chromium, stainless steel, zinc, Biolimus A9™, or contrast media not adequately pre-medicated
- PCI within the previous 12 months
- Participation in another clinical study within 12 months after index procedure
- Life expectancy less than 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Hospital Sultanah Aminah
Johor Bahru, Johor, Malaysia
Actively Recruiting
2
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Actively Recruiting
3
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
Actively Recruiting
4
Hospital Queen Elizabeth II
Kota Kinabalu, Sabah, Malaysia
Actively Recruiting
5
Pusat Jantung Hospital Umum Sarawak
Kota Kinabalu, Sarawak, Malaysia
Actively Recruiting
6
Hospital Serdang
Kajang, Selangor, Malaysia
Actively Recruiting
Research Team
K
Kar Imm Ang, MSc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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