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Compares treatment options for Coronary Artery Disease
Official title LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
ClinicalTrials.gov ID: NCT06657326
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.
You likely can't join if
- Pregnant and breastfeeding women
- Age \<18 years old
- Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
- Patients expected not to comply with 1 month DAPT
- Active bleeding at the time of inclusion
- Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy...
See the full eligibility criteria
- 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)...
- Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.
- Pregnant and breastfeeding women
- Age \<18 years old
- Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
- Patients expected not to comply with 1 month DAPT
- Active bleeding at the time of inclusion
- 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 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)
- Patient with chronic total occlusion(s) as target lesion(s)
- 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...
- Cardiogenic shock
- Compliance with long-term single anti-platelet therapy unlikely
- 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...
- Any PCI during the previous 12 months
- Participation in another clinical study (12 months after index procedure)
- Patients with a life expectancy of \<12 months
The study team makes the final eligibility decision.
Where it's taking place
- Johor Bahru, Johor, Malaysia
- Kuantan, Pahang, Malaysia
- Ipoh, Perak, Malaysia
- Kota Kinabalu, Sabah, Malaysia
- Kota Kinabalu, Sarawak, Malaysia
- Kajang, Selangor, Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Johor Bahru, Johor, Malaysia; Kuantan, Pahang, Malaysia; Ipoh, Perak, Malaysia; Kota Kinabalu, Sabah, Malaysia; Kota Kinabalu, Sarawak, Malaysia; Kajang, Selangor, Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.