RecruitingNCT06066450

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

Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis: Multi-center, Prospective, Observational Study (OSFIT Registry)


Sponsor

Genoss Co., Ltd.

Enrollment

1,000 participants

Start Date

Jul 7, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Genoss® DES system, Genoss® Osfit system for people with coronary artery disease and drug-eluting stent. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGenoss® 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

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NCT06066450


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