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

Recruiting N/A Interventional Study
Coronary Artery Disease Chronic Stable Angina Unstable Angina Silent Ischemia Acute Coronary Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
444 (estimated)
Sponsor
Biosensors Europe SA · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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 stenosi…
Contacts

Kar Imm Ang, MSc.

+65 6213 0142

ki.ang@biosensors.com

CONTACT