Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-31 @ 3:00 AM
Study NCT ID:
NCT06066450
Status:
RECRUITING
Last Update Posted:
2023-11-01
First Post:
2023-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2023-09-27', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Targeted lesion failure', 'timeFrame': '12 months', 'description': 'A composite of cardiac death, target-vessel MI, or target lesion revascularization'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiovascular events', 'timeFrame': '12 months', 'description': 'A composite of all-cause death, MI, or revascularization'}, {'measure': 'All-cause death', 'timeFrame': '12 months', 'description': 'All-cause death and cardiac death'}, {'measure': 'Any MI', 'timeFrame': '12 months', 'description': 'Any MI and target vessel MI'}, {'measure': 'Any revascularization', 'timeFrame': '12 months', 'description': 'Any revascularization and ischemic driven target lesion revascularization'}, {'measure': 'Major bleeding events, BARC 3, 5', 'timeFrame': '12 months', 'description': 'A composite rate of major bleeding events, BARC 3, 5'}, {'measure': 'Any Stroke', 'timeFrame': '12 months', 'description': 'Ischemic or hemorrhagic stroke'}, {'measure': 'Any stent thrombosis', 'timeFrame': '12 months', 'description': 'efinite or probable stent thrombosis (acute, subacute, late)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug-eluting Stent', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': "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.\n\nIn 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.\n\nTo 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.\n\nSubgroup analysis will include an imaging analysis of stent insertion adequacy in the group where OCT was performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A patient with stenosis within 5mm of the coronary artery ostium who qualifies for percutaneous coronary intervention with drug-eluting stents', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 19 and above.\n2. Patients who have voluntarily decided to participate in this study and have provided written consent in accordance with the subject's agreement.\n3. 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.)\n\nExclusion Criteria:\n\n1. Patients with contraindications to stent treatment and antiplatelet therapy or who have hypersensitivity.\n2. Patients with a life expectancy of less than 1 year.\n3. Pregnant or lactating women, or those wishing to become pregnant.\n4. Patients with ST-elevation myocardial infarction (STEMI)."}, 'identificationModule': {'nctId': 'NCT06066450', 'briefTitle': 'Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genoss Co., Ltd.'}, 'officialTitle': 'Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis: Multi-center, Prospective, Observational Study (OSFIT Registry)', 'orgStudyIdInfo': {'id': 'AJOUIRBOB2023268'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OSFITTM drug-eluting stents.', 'description': 'Treatment Group: Group of patients who received treatment with OSFITTM drug-eluting stents.\n\nSubgroup with OCT (OCT Subgroup): Subgroup of patients who underwent Optical Coherence Tomography (OCT) to verify stent placement accuracy.', 'interventionNames': ['Device: Genoss® DES system, Genoss® Osfit system']}], 'interventions': [{'name': 'Genoss® DES system, Genoss® Osfit system', 'type': 'DEVICE', 'otherNames': ['GENOSS DES(Sirolimus Drug Eluting Coronary Stent) System, Osfit Sirolimus Drug Eluting Coronary Stent System'], 'description': '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.', 'armGroupLabels': ['OSFITTM drug-eluting stents.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16499', 'city': 'Suwon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Je Hwan Won, MD', 'role': 'CONTACT', 'email': 'wonkwak@ajou.ac.kr', 'phone': '82312195863'}], 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'seong-jae TaK, MD, PhD', 'role': 'CONTACT', 'email': 'stjahk@gmail.com', 'phone': '820312195712'}, {'name': 'Nayeong Lee, RN', 'role': 'CONTACT', 'email': 'yellowfox240@gmail.com', 'phone': '820312195111'}], 'overallOfficials': [{'name': 'seong-jae TaK, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genoss Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}