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BioFreedom Ultra Registry

Recruitingn/aAges 18 Years - anyAllChinese University of Hong Kong
NCT05094284 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 (84ฮผm), 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 LEADE

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: This is an "all comers" registry and patient who will be enrolled have to meet following criteria: * Patient must be at least 18 years of age * Patient must have indication to percutaneous coronary intervention including: * Stable angina or evidence of myocardial ischemia with stress echocardiography/ myocardial SPECT/exercise test, or * Unstable angina / non ST-elevation myocardial infarction, OR * ST-elevation myocardial infarction with de novo culprit lesion. * Presence of one or more coronary artery stenosis \>50% with reference diameter 2.0-6.0mm which can be covered by one or multiple stents Exclusion Criteria: * Known intolerance to any of the device components * Inability to provide written informed consent * Participating in other trial before reaching primary endpoint * Planned surgery within 1 month of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.
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What it tests

  • BioFreedom Ultra
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Where

1 site
Prince of Wales Hospital
Shatin, Hong Kong
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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