Evaluating the OSFIT drug-eluting stent for coronary artery stenosis
Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis: Multi-center, Prospective, Observational Study (OSFIT Registry)
This study is testing whether the OSFIT drug-eluting stent is safe and effective for people with narrowed coronary arteries near the heart's main opening, following them for a year after their procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Genoss Co., Ltd. Industry-sponsored |
| Locations | 1 site (Suwon) |
| Trial ID | NCT06066450 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term effectiveness and safety of the OSFIT drug-eluting stent in patients with coronary artery stenosis located within 5mm of the coronary ostium. A total of 1000 patients who have undergone percutaneous coronary intervention (PCI) will be enrolled and followed for up to 12 months. The study will also utilize Optical Coherence Tomography (OCT) to evaluate the accuracy of stent placement in a subgroup of participants. The primary endpoint includes measuring target lesion failure at the 12-month mark, which encompasses cardiac death, target vessel myocardial infarction, or target lesion revascularization.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and above who have undergone PCI for coronary artery stenosis near the ostium using OSFIT drug-eluting stents.
Not a fit: Patients with contraindications to stent treatment, those with a life expectancy of less than one year, or those with ST-elevation myocardial infarction will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with coronary artery disease by validating the effectiveness of the OSFIT drug-eluting stent.
How similar studies have performed: Other studies have shown success with drug-eluting stents in similar contexts, but the specific application of the OSFIT stent is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Suwon
- Ajou University Hospital — Suwon, South Korea (Recruiting)
Study contacts
- Principal investigator: seong-jae TaK, MD, PhD — Ajou University School of Medicine
- Study coordinator: seong-jae TaK, MD, PhD
- Email: stjahk@gmail.com
- Phone: 820312195712
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.