Evaluating the OSFIT drug-eluting stent for coronary artery stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.