NCT06066450

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Jul 2023Dec 2026

Study Start

First participant enrolled

July 7, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 1, 2023

Status Verified

September 1, 2023

Enrollment Period

3.5 years

First QC Date

September 27, 2023

Last Update Submit

October 30, 2023

Conditions

Drug-eluting StentCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Targeted lesion failure

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

    12 months

Secondary Outcomes (7)

  • Major adverse cardiovascular events

    12 months

  • All-cause death

    12 months

  • Any MI

    12 months

  • Any revascularization

    12 months

  • Major bleeding events, BARC 3, 5

    12 months

  • +2 more secondary outcomes

Study Arms (1)

OSFITTM drug-eluting stents.

Treatment Group: Group of patients who received treatment with OSFITTM drug-eluting stents. Subgroup with OCT (OCT Subgroup): Subgroup of patients who underwent Optical Coherence Tomography (OCT) to verify stent placement accuracy.

Device: Genoss® DES system, Genoss® Osfit system

Interventions

Genoss® DES system, Genoss® Osfit systemDEVICE

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.

Also known as: GENOSS DES(Sirolimus Drug Eluting Coronary Stent) System, Osfit Sirolimus Drug Eluting Coronary Stent System
OSFITTM drug-eluting stents.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, 16499, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • seong-jae TaK, MD, PhD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

seong-jae TaK, MD, PhD

CONTACT

820312195712stjahk@gmail.com

Nayeong Lee, RN

CONTACT

820312195111yellowfox240@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 4, 2023

Study Start

July 7, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 1, 2023

Record last verified: 2023-09

Locations

KR(1)