Actively Recruiting

Age: 19Years +
All Genders
NCT06066450

Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis

Led by Genoss Co., Ltd. · Updated on 2023-11-01

1000

Participants Needed

1

Research Sites

181 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19 and above
  • Patients who voluntarily agree to participate and provide written consent
  • Patients who underwent percutaneous coronary intervention for stenosis within 5mm of the coronary artery ostium using OSFIT drug-eluting stents
  • If stenting other lesions at the same time, only Genoss drug-eluting stents are allowed for those lesions
Not Eligible

You will not qualify if you...

  • Patients with contraindications to stent treatment or antiplatelet therapy, including hypersensitivity
  • Patients with a life expectancy less than 1 year
  • Pregnant or breastfeeding women, or those planning pregnancy
  • Patients with ST-elevation myocardial infarction (STEMI)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ajou University Hospital

Suwon, South Korea, 16499

Actively Recruiting

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Research Team

S

seong-jae TaK, MD, PhD

CONTACT

N

Nayeong Lee, RN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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