Status:
RECRUITING
Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis
Lead Sponsor:
Genoss Co., Ltd.
Conditions:
Drug-eluting Stent
Coronary Artery Disease
Eligibility:
All Genders
19+ years
Brief Summary
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...
Detailed Description
Investigator plan to enroll a total of 1000 patients who underwent percutaneous coronary intervention (PCI) for coronary artery stenosis within 5mm of the coronary artery ostium using OSFIT drug-eluti...
Eligibility Criteria
Inclusion
- Age 19 and above.
- Patients who have voluntarily decided to participate in this study and have provided written consent in accordance with the subject's agreement.
- 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
- Patients with contraindications to stent treatment and antiplatelet therapy or who have hypersensitivity.
- Patients with a life expectancy of less than 1 year.
- Pregnant or lactating women, or those wishing to become pregnant.
- Patients with ST-elevation myocardial infarction (STEMI).
Key Trial Info
Start Date :
July 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06066450
Start Date
July 7 2023
End Date
December 31 2026
Last Update
November 1 2023
Active Locations (1)
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1
Ajou University Hospital
Suwon, South Korea, 16499