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

Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis: Multi-center, Prospective, Observational Study (OSFIT Registry)

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Drug-eluting Stent
• Intervention / Treatment: Device: Genoss® DES system, Genoss® Osfit system

Detailed Description

Investigator plan to enroll a total of 1000 patients who underwent percutaneous coronary intervention (PCI) for coronary artery stenosis within 5mm of the coronary artery ostium using OSFIT drug-eluting stents, with the condition that only GenossTM drug-eluting stents are used if stenting is performed simultaneously in other lesions. These patients will be followed for up to 12 months.

In addition, a subgroup analysis will be conducted using Optical Coherence Tomography (OCT) to assess the accuracy of OSFIT stent placement immediately after the procedure. OCT catheter use will involve the investigation and follow-up of 50 patients each at Ajou University Hospital and Samsung Seoul Hospital. Statistical analysis will involve categorical variables presented as percentages and numbers, compared using the chi-square or Fisher exact test. Continuous variables will be described using means, standard deviations, or medians and interquartile ranges and compared using Student's t-test or the Wilcoxon rank-sum test. The normality of baseline variable distributions will be assessed using histograms, skewness, kurtosis, and the Kolmogorov-Smirnov one-sample test. Kaplan-Meier analysis of cumulative rates of primary and secondary evaluation variables will be performed using the log-rank test.

To identify potential associations with clinical outcomes, all variables showing potential relevance to clinical outcomes will be tested through univariate Cox regression analysis. In order to reduce bias in retrospective studies, a multivariate Cox proportional hazard model will be used to test variables that have a significant impact (p-value < 0.1) in the univariate analysis.

Subgroup analysis will include an imaging analysis of stent insertion adequacy in the group where OCT was performed.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: seong-jae TaK, MD, PhD; Phone Number: 820312195712; Email: stjahk@gmail.com
• Study Contact Backup: Name: Nayeong Lee, RN; Phone Number: 820312195111; Email: yellowfox240@gmail.com

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of, 16499
    • Recruiting
    • Ajou University Hospital
    • Contact: Je Hwan Won, MD; Phone Number: 82312195863; Email: wonkwak@ajou.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Other Names: GENOSS DES(Sirolimus Drug Eluting Coronary Stent) System, Osfit Sirolimus Drug Eluting Coronary Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Targeted lesion failure	A composite of cardiac death, target-vessel MI, or target lesion revascularization	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events	A composite of all-cause death, MI, or revascularization	12 months
All-cause death	All-cause death and cardiac death	12 months
Any MI	Any MI and target vessel MI	12 months
Any revascularization	Any revascularization and ischemic driven target lesion revascularization	12 months
Major bleeding events, BARC 3, 5	A composite rate of major bleeding events, BARC 3, 5	12 months
Any Stroke	Ischemic or hemorrhagic stroke	12 months
Any stent thrombosis	efinite or probable stent thrombosis (acute, subacute, late)	12 months

Collaborators and Investigators

• Sponsor: Genoss Co., Ltd.
• Investigators: Principal Investigator: seong-jae TaK, MD, PhD, Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: September 27, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Protein Kinase Inhibitors; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus; Temsirolimus; MTOR Inhibitors
• Other Study ID Numbers: AJOUIRBOB2023268

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No