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

Last updated: October 30, 2023
Sponsor: Genoss Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Hypercholesterolemia

Thrombosis

Treatment

Genoss® DES system, Genoss® Osfit system

Clinical Study ID

NCT06066450
AJOUIRBOB2023268
  • Ages > 19
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 19 and above.
  2. Patients who have voluntarily decided to participate in this study and have providedwritten consent in accordance with the subject's agreement.
  3. Patients who have undergone percutaneous coronary intervention for stenosis within 5mmof the ostium of the coronary artery using OSFITTM drug-eluting stents. (In case ofsimultaneous stent placement for other lesions, only GenossTM drug-eluting stentsshould be used.)

Exclusion

Exclusion Criteria:

  1. Patients with contraindications to stent treatment and antiplatelet therapy or whohave 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 Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Genoss® DES system, Genoss® Osfit system
Phase:
Study Start date:
July 07, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Ajou University Hospital

    Suwon, 16499
    Korea, Republic of

    Active - Recruiting

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