NCT06066450 Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis
| NCT ID | NCT06066450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Genoss Co., Ltd. |
| Condition | Drug-eluting Stent |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-07-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-07-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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
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).
Contact & Investigator
seong-jae TaK, MD, PhD
PRINCIPAL INVESTIGATOR
Ajou University School of Medicine
Frequently Asked Questions
Who can join the NCT06066450 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Drug-eluting Stent. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06066450 currently recruiting?
Yes, NCT06066450 is actively recruiting participants. Contact the research team at stjahk@gmail.com for enrollment information.
Where is the NCT06066450 trial being conducted?
This trial is being conducted at Suwon, South Korea.
Who is sponsoring the NCT06066450 clinical trial?
NCT06066450 is sponsored by Genoss Co., Ltd.. The principal investigator is seong-jae TaK, MD, PhD at Ajou University School of Medicine. The trial plans to enroll 1,000 participants.