Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorGenoss Co., Ltd.
About this trial
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 criteria
Qualifiers
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.)
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Genoss® DES system, Genoss® Osfit system
Treatment groups
1,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov