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Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis

Recruitingn/aAges 19 Years - anyAllGenoss Co., Ltd.
NCT06066450 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this observational study is to evaluate the long-term effectiveness and safety of the OSFIT drug-eluting stent designed to facilitate procedures in coronary artery lesions. Additionally, the study aims to verify the accuracy of stent placement in the lesion of interest using Optical Coherence Tomography (OCT) among subgroups of participants. The primary endpoint was defined as the composite of target lesion failure (TLF) at the 12-month mark, including cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 19 and above. 2. Patients who have voluntarily decided to participate in this study and have provided written consent in accordance with the subject's agreement. 3. Patients who have undergone percutaneous coronary intervention for stenosis within 5mm of the ostium of the coronary artery using OSFITTM drug-eluting stents. (In case of simultaneous stent placement for other lesions, only GenossTM drug-eluting stents should be used.) Exclusion Criteria: 1. Patients with contraindications to stent treatment and antiplatelet therapy or who have hypersensitivity. 2. Patients with a life expectancy of less than 1 year. 3. Pregnant or lactating women, or those wishing to become pregnant. 4. Patients with ST-elevation myocardial infarction (STEMI).
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What it tests

  • Genoss® DES system, Genoss® Osfit system
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Where

1 site
Ajou University Hospital
Suwon, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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