Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT06168305
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-06
First Post:
2023-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure (TLF)', 'timeFrame': 'at 12 months after the procedure', 'description': 'The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization)'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiac events (MACE)', 'timeFrame': 'at 12 months after the procedure', 'description': 'The composite end point of death, myocardial infarction, target lesion revascularization'}, {'measure': 'Cardiac death', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'Non-cardiac death', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'TV-MI (target vessel-myocardial infarction)', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'Non-target vessel myocardial infarction', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'ID-TVR (ischemia-driven target vessel revascularization)', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'Non-ischemia driven target vessel revascularization', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'Incidence rate of acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year', 'timeFrame': 'within 24 hours, 30 days, 1 year', 'description': 'Acute (within 24 hours), subacute (within 30 days), late (within 1 year)'}, {'measure': 'Device success', 'timeFrame': 'during the procedure', 'description': 'The clinical device is successfully delivered to the target lesion, inflated normally, and recovered intact.'}, {'measure': 'Procedure success', 'timeFrame': 'during the hospitalization period (up to 3 days)', 'description': 'When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedural death, myocardial infarction, or revascularization during the hospitalization period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Percutaneous Coronary Intervention', 'Multivessel Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The investigators intend to establish a multicenter prospective observational study by enrolling and tracking patients with multivessel coronary artery disease (MVCAD) using Genoss DES, a device manufactured with pure domestic technology. The study aims to evaluate the efficacy and safety of Genoss DES in MVCAD patients.', 'detailedDescription': 'This study is a sponsor-driven clinical trial (SIT) that aims to enroll patients who have undergone treatment for multivessel coronary artery disease using Genoss stents. The study involves collecting data on the clinical and surgical processes of patients and tracking the occurrence of clinical events.\n\nThis prospective, multicenter observational study registers patients with acute coronary artery disease who have been treated with GENOSS stents at a total of 8 institutions.\n\nAs it is an observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants during the study registration period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with multivessel coronary artery disease (MVCAD) who underwent percutaneous coronary intervention using GENOSS® DES', 'eligibilityCriteria': '\\<Inclusion Criteria\\>\n\n* Adults over 19 years of age\n* Subjects with multivessel coronary artery disease (MVCAD) (However, subject registration is possible even if the treatment area is restenosis or recurrent lesion, including new lesions)\n* Subjects who underwent percutaneous coronary intervention (PCI) with GENOSS® DES\n* Research subjects who agree to the research protocol and clinical follow-up plan, voluntarily decide to participate in this clinical study, and give written consent in the informed consent form.\n\n(However, in the case of foreigners, only those who can speak Korean fluently and understand Korean documents such as the consent form are included.)\n\n\\<Exclusion Criteria\\>\n\n* Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded)\n* When balloon angioplasty is performed on a stenotic area, the balloon cannot be expanded.\n* Those whose remaining life expectancy is less than 1 year\n* Expecting to become pregnant, pregnant or lactating woman\n* The patient was admitted to the hospital due to cardiogenic shock and was predicted to have a low chance of survival based on medical judgment.\n\nSubject\n\n* If the researcher determines that the product is not suitable for this clinical study or may increase the risks associated with participation in the study.\n* Foreigners who cannot speak Korean fluently and have difficulty understanding Korean documents'}, 'identificationModule': {'nctId': 'NCT06168305', 'acronym': 'GENOSS-MV', 'briefTitle': 'Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genoss Co., Ltd.'}, 'officialTitle': 'Safety and Effectiveness of GENOSS® DES (Sirolimus-eluting Coronary Stent System) in Patients With Multivessel Coronary Artery Disease (MVCAD): A Multicenter, Prospective, Observational Study', 'orgStudyIdInfo': {'id': '2023GR0399'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]', 'description': 'Patients with multivessel coronary artery disease (MVCAD) who underwent percutaneous coronary intervention using GENOSS® DES', 'interventionNames': ['Device: GENOSS® DES Sirolimus Eluting Coronary Stent System']}], 'interventions': [{'name': 'GENOSS® DES Sirolimus Eluting Coronary Stent System', 'type': 'DEVICE', 'description': 'The GENOSS® DES is L-605 cobalt chromium (CoCr) platform with a strut thickness of 70µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.', 'armGroupLabels': ['GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08308', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University GURO Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genoss Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}