Actively Recruiting
BioFreedom Ultra Registry
Led by Chinese University of Hong Kong · Updated on 2022-09-22
300
Participants Needed
1
Research Sites
350 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Over the past three decades, coronary stent struts have been made progressively thinner. Thin strut drug-eluting stents (DES) performed better than their thicker counterparts in a recent study. Thinner struts discourage abnormal coronary flow after implantation and associated with greater flexibility, deliverability and better clinical outcomes. Lower strut thickness may be particularly advantageous in small target vessels because thicker struts and smaller minimum in-stent lumen diameter are independent predictors of in-stent restenosis. BioFreedom Ultra is a thin strut (84μm), cobalt-chromium, carrier-free drug-coated stent with Biolimus A9 drug. The BioFreedom Ultra stent is intended for percutaneous coronary intervention (PCI) for high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy. BioFreedom Ultra received CE mark in October 2020 supported by the LEADERS FREE III trial which enrolled 400 HBR patients using the same inclusion criteria as the LEADERS FREE randomized trial. LEADERS FREE III is a single-arm trial, with all patients treated using the BioFreedom Ultra stent. The data was compared to the BioFreedom stainless steel drug-coated stent (DCS-StS) and bare-metal stent (BMS) groups from LEADERS FREE. The primary safety endpoint of the trial was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization. The study found that the BioFreedom Ultra was non-inferior to the DCS-StS for safety and superior to the BMS for efficacy. Definite or probable stent thrombosis at 1 year in this HBR population was only 1%. Recently, the Biofreedom QCA randomized trial compared the Biofreedom Ultra with the stainless steel version (DCS-StS) in an all-comer population. In this prospective, single-blind non-inferiority randomized (1:1) trial, BioFreedom Ultra was non-inferiority for late lumen loss at 9 months in comparison with DCS-StS.
CONDITIONS
Official Title
BioFreedom Ultra Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be at least 18 years of age
- Patient must have indication for percutaneous coronary intervention such as stable angina or evidence of myocardial ischemia via stress echocardiography, myocardial SPECT, or exercise test
- Patient may have unstable angina or non ST-elevation myocardial infarction
- Patient may have ST-elevation myocardial infarction with a new culprit lesion
- Presence of one or more coronary artery stenosis greater than 50% with reference diameter 2.0-6.0 mm suitable for one or multiple stents
You will not qualify if you...
- Known intolerance to any components of the BioFreedom Ultra stent
- Inability to provide written informed consent
- Currently participating in another trial before reaching the primary endpoint
- Planned surgery within one month of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Actively Recruiting
Research Team
D
Daniel Xu
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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