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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent and a medical device called BioFreedom™ stainless steel Biolimus A9™-coated stent for people with acute coronary syndrome, chronic stable angina, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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