Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2025-12-27 @ 2:38 PM
Study NCT ID:
NCT06075368
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-19
First Post:
2023-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of GENOSS® SES in Patients with Acute Coronary Syndrome (GENOSS ACS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 757}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-16', 'studyFirstSubmitDate': '2023-10-04', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety evaluation', 'timeFrame': '1 month, 12 months, 2 years, 3 years after the procedure', 'description': 'Occurrence of stent-related events (cardiac death, myocardial infarction, stent thrombosis, bleeding, etc.) and any damage or complications that are believed to be related to the procedure.'}], 'primaryOutcomes': [{'measure': 'Device-oriented composite endpoint', 'timeFrame': '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': 'Target lesion failure (TLF)', 'timeFrame': '3 years after the procedure', 'description': 'Target lesion failure (TLF) is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR).'}, {'measure': 'Target vessel failure (TVF)', 'timeFrame': '3 years after the procedure', 'description': 'Target vessel failure (TVF) is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-vessel revascularization (TVR).'}, {'measure': 'All-cause death', 'timeFrame': '3 years after the procedure'}, {'measure': 'Cardiac death', 'timeFrame': '3 years after the procedure'}, {'measure': 'All-cause death and any myocardial infarction', 'timeFrame': '3 years after the procedure'}, {'measure': 'Cardiac death and target vessel-related myocardial infarction', 'timeFrame': '3 years after the procedure'}, {'measure': 'Target vessel revascularization (TVR)', 'timeFrame': '3 years after the procedure'}, {'measure': 'Target lesion revascularization (TLR)', 'timeFrame': '3 years after the procedure'}, {'measure': 'Stent thrombosis', 'timeFrame': '3 years after the procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACS'], 'conditions': ['Acute Coronary Syndrome', 'Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy and safety of the GENOSS SES in patients with acute coronary syndrome (ACS) in real-world pratice.', 'detailedDescription': 'The Genoss SES 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 the Genoss SES in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention.\n\nThe Genoss SES study is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss SES implantation in ACS patients undergoing percutaneous coronary intervention from 10 sites in South Korea. The primary endpoint was a device-oriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 10 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute coronary syndrome treated with the GENOSS SES', 'healthyVolunteers': False, 'eligibilityCriteria': '\\<Inclusion Criteria\\>\n\n1. Patients of 19 and over\n2. Patients with acute coronary syndrome 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\n\\<Exclusion Criteria\\>\n\n1. Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents\n\n \\- However, patients with hypersensitivity to contrast agents may be eligible if it can be controlled by steroids and pheniramine. Patients with known anaphylaxis are excluded\n2. Patients who are pregnant or planning to become pregnant\n3. Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration.\n4. Patients with a life expectancy of less than 1 year\n5. Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment.\n6. Patients who have already received treatment with another DES (Drug Eluting Stent), BVS (Bioresorbable Vascular Scaffolds), or BMS (Bare Metal Stent) at the time of registration.\n7. Patients currently participating in a randomized controlled trial involving medical devices.'}, 'identificationModule': {'nctId': 'NCT06075368', 'acronym': 'GENOSS ACS', 'briefTitle': 'Efficacy and Safety of GENOSS® SES in Patients with Acute Coronary Syndrome (GENOSS ACS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genoss Co., Ltd.'}, 'officialTitle': 'A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS SES in Patients with Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'CIP-DS0501-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]', 'description': 'Patients with acute coronary syndrome treated with the GENOSS SES', 'interventionNames': ['Device: GENOSS Sirolimus Eluting Coronary Stent System']}], 'interventions': [{'name': 'GENOSS Sirolimus Eluting Coronary Stent System', 'type': 'DEVICE', 'description': 'The GENOSS SES is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt chromium stent platform and thin strut.', 'armGroupLabels': ['GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genoss Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}