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

NCT06066450 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-11-01

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Genoss® DES system, Genoss® Osfit system

This is a drug-eluting stent used to improve the diameter of the coronary artery in patients with symptomatic ischemic heart disease, with de novo lesions in the native coronary artery, where the reference vessel diameter ranges from 2.25mm to 5.00mm.

Sponsors & Collaborators

  • Genoss Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • seong-jae TaK, MD, PhD · Ajou University School of Medicine

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-07
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06066450 on ClinicalTrials.gov