NCT06066450Recruiting
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)
Source: ClinicalTrials.gov · Last updated 1 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 27 Sept 2023
- Start date
- 7 Jul 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Genoss Co., Ltd.
- Diseases
- Coronary artery disease
- NCT number
- NCT06066450
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 7 Jul 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with contraindications to stent treatment and antiplatelet therapy or who have hypersensitivity.
- Patients with ST-elevation myocardial infarction (STEMI).
Other
- Patients with a life expectancy of less than 1 year.
- Pregnant or lactating women, or those wishing to become pregnant.
Who the study is looking for
- 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.)
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.