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Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis
Sponsor: Genoss Co., Ltd.
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, 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.
Official title: Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis: Multi-center, Prospective, Observational Study (OSFIT Registry)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2023-07-07
Completion Date
2026-12-31
Last Updated
2023-11-01
Healthy Volunteers
No
Interventions
Genoss® DES system, Genoss® Osfit system
This is a drug-eluting stent used to improve the diameter of the coronary artery in patients with symptomatic ischemic heart disease, with de novo lesions in the native coronary artery, where the reference vessel diameter ranges from 2.25mm to 5.00mm.
Locations (1)
Ajou University Hospital
Suwon, South Korea