Clinical trial NCT06066450: Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis
Official title: Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis: Multi-center, Prospective, Observational Study (OSFIT Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drug-eluting Stent
Coronary Artery Disease
Lead sponsor: Genoss Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Targeted lesion failure
timeFrame: 12 months
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 12 months
measure: All-cause death
timeFrame: 12 months
measure: Any MI
timeFrame: 12 months
measure: Any revascularization
timeFrame: 12 months
measure: Major bleeding events, BARC 3, 5
timeFrame: 12 months
measure: Any Stroke
timeFrame: 12 months
measure: Any stent thrombosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Ajou University School of Medicine
name: seong-jae TaK, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: