RecruitingNot ApplicableNCT06657326

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

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

Sponsor

Biosensors Europe SA

Enrollment

444 participants

Start Date

Dec 18, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Stable Angina Acute Coronary Syndrome Coronary Artery Disease Unstable Angina Silent Ischemia

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

Min Age: 18 Years

Inclusion Criteria2

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).
Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.

Exclusion Criteria20

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 rotational or orbital atherectomy is also permitted.
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 be adequately pre-medicated
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