Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT06075433
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2023-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of 1-year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-risk Procedure
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'}]}}, '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': '2022-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2023-10-04', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device-oriented composite endpoint', 'timeFrame': 'at 12 months after the procedure', 'description': 'DOCE is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR).'}], 'secondaryOutcomes': [{'measure': 'Patient-oriented composite endpoint', 'timeFrame': 'at 12 months after the procedure', 'description': 'POCE is defined as a composite of all-cause death, any myocardial infarction, and any revascularization.'}, {'measure': 'All-cause deaths', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'Cardiac death', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'Non-cardiac death', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'Any myocardial infarction', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'Target vessel-realted myocardial infarction (TV-MI)', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'Any revascularization', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'Revascularization of clinically appropriate target lesions', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'Stent thrombosis by ARC definition', 'timeFrame': 'at 12 months after the procedure'}, {'measure': 'Lesion success', 'timeFrame': 'during the procedure', 'description': 'When the final residual lesion stenosis is less than 30% using any surgical method.'}, {'measure': 'Procedure success', 'timeFrame': 'immediately after the procedure', 'description': 'When the final residual lesion stenosis is less than 30% using any surgical method, and there is no post-procedure death, myocardial infarction, or revascularization during the hospitalization period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Percutaneous Coronary Intervention', 'Dual Antiplatelet Therapy']}, 'descriptionModule': {'briefSummary': 'The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.', 'detailedDescription': 'The Genoss DES is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.\n\nThe Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of 1 year duration of DAPT after Genoss DES implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure from 9 sites in South Korea. The primary endpoint was a deviceoriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 12 months. The key secondary endpoint was a patient-oriented composite endpoint (POCE), defined as a composite of all-cause death, any myocardial infarction, and any revascularization at 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease treated with GENOSS DES', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of 19 and over\n2. Patients with coronary artery disease treated with GENOSS SES\n3. Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants\n\nExclusion Criteria:\n\n1. Patients with cardiogenic shock at the time of hospitalization\n2. Patients who are pregnant or planning to become pregnant\n3. Patients with a life expectancy of less than 1 year\n4. Patients participating in randomized controlled trials using other medical devices\n5. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration (However, other stent insertions are allowed due to failure of GENOSS DES insertion)'}, 'identificationModule': {'nctId': 'NCT06075433', 'acronym': 'DAPTLong', 'briefTitle': 'Efficacy and Safety of 1-year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-risk Procedure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genoss Co., Ltd.'}, 'officialTitle': 'A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of 1 Year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-Risk Procedure', 'orgStudyIdInfo': {'id': 'CIP-DS0501-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GENOSS Sirolimus Eluting Coronary Stent System', 'description': 'Patients with coronary artery disease treated with the GENOSS DES\n\n\\<Definition of a complex high-risk patients\\>\n\n1. Clinical factors\n\n * Age 75 or older\n * History of diabetes (those who have had diabetes in the past or are taking diabetes medication)\n * History of chronic kidney disease (GFR \\<60ml/min/1.73m2) or dialysis\n * History of stroke\n * History of coronary artery bypass graft\n * Left ventricular dysfunction (LVEF \\<40%)\n * Severe valve disease\n * Acute coronary syndrome with positive troponin levels\n2. Lesion/procedure factors\n\n * Left main lesion\n * Chronic total occlusion\n * Bifurcation lesion with branches larger than 2 mm\n * Calcified lesion (moderate to severe calcified lesion)\n * Restenosis lesion (in-stent restenosis)\n * Multivessel PCI\n * Three or more stents implanted (≥3 stents implanted)\n * When the stent length of one lesion is more than 50 mm (total stent length \\>50 mm in a lesion)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wŏnju', 'state': 'Gangwon State', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Jin youn', 'role': 'CONTACT', 'email': 'younyj@yonsei.ac.kr', 'phone': '033-741-0910'}], 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'centralContacts': [{'name': 'YoungJin Youn', 'role': 'CONTACT', 'email': 'younyj@yonsei.ac.kr', 'phone': '033-741-0910'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No The data set is available from the the corresponding author upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genoss Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}