Health TrialsbyHealthPanel

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

ConditionsDrug-eluting StentCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorGenoss Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.)

Disqualifiers

Patients with contraindications to stent treatment and antiplatelet therapy or who have hypersensitivity.

Patients with a life expectancy of less than 1 year.

Pregnant or lactating women, or those wishing to become pregnant.

Patients with ST-elevation myocardial infarction (STEMI).

Trial population

A patient with stenosis within 5mm of the coronary artery ostium who qualifies for percutaneous coronary intervention with drug-eluting stents

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Genoss® DES system, Genoss® Osfit system

    Device

    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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: OSFITTM drug-eluting stents.1 intervention

Trial outcomes

Primary outcomes

1

Targeted lesion failure

A composite of cardiac death, target-vessel MI, or target lesion revascularization

Time frame
12 months

Secondary outcomes

1

Major adverse cardiovascular events

A composite of all-cause death, MI, or revascularization

Time frame
12 months
2

All-cause death

All-cause death and cardiac death

Time frame
12 months
3

Any MI

Any MI and target vessel MI

Time frame
12 months
4

Any revascularization

Any revascularization and ischemic driven target lesion revascularization

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genoss Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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