Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-27 @ 11:38 AM
Study NCT ID:
NCT05658250
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2022-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CREATE Trial, Prospective, Observational Study
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': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2022-12-12', 'studyFirstSubmitQcDate': '2022-12-19', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion failure including deaht, MI, ST, TLR', 'timeFrame': '12 months after the index procedure', 'description': 'number of Target lesion failure including deaht, MI, ST, TLR'}], 'secondaryOutcomes': [{'measure': 'All cause death', 'timeFrame': '12 months after the index procedure', 'description': 'number of All cause death'}, {'measure': 'Cardiac death', 'timeFrame': '12 months after the index procedure', 'description': 'number of Cardiac death'}, {'measure': 'Myocardial infarction', 'timeFrame': '12 months after the index procedure', 'description': 'number of Myocardial infarction'}, {'measure': 'Stent thrombosis : definite or probable stent thrombosis by ARC definition', 'timeFrame': '12 months after the index procedure', 'description': 'number of Stent thrombosis'}, {'measure': 'Target lesion revascularization', 'timeFrame': '12 months after the index procedure', 'description': 'number of Target lesion revascularization'}, {'measure': 'Target vessel revascularization', 'timeFrame': '12 months after the index procedure', 'description': 'number of Target vessel revascularization'}, {'measure': 'Stroke', 'timeFrame': '12 months after the index procedure', 'description': 'number of Stroke'}, {'measure': 'BARC bleeding 2-5', 'timeFrame': '12 months after the index procedure', 'description': 'number of BARC bleeding 2-5'}, {'measure': 'Stent overexpansion by OCT', 'timeFrame': 'immediately after the index procedure in hospitalization', 'description': 'Maximal stent diameter/ each diameter of stent'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Drug Eluting Stent']}, 'descriptionModule': {'briefSummary': 'Observation of the safety and effectiveness of Cre8 stent, Cre8 evo stent in patients with ischemic heart disease with long coronary lesions', 'detailedDescription': 'The purpose of this study is to observe the prognosis of 300 patients with long lesions over 30 mm treated with a new-generation Cre8 stent, Cre8 evo stent that is polymer-free and releases fat-soluble ampilimus in the real world. In addition, in the case of inserting a 46mm very long stent through sub-analysis, we also want to check whether stent expansion is performed through OCT rather than IVUS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '300 patients underwent Cre 8 stent, Cre8 evo stent implantation of 30 mm or more', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 19 years of age or older\n2. Clinical evidence of coronary artery disease, including asymptomatic ischemia, stable angina, and acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, ST-segment elevation myocardial infarction)\n3. Coronary artery lesion length 30 mm or more\n4. Those who voluntarily agreed in writing to participate in this clinical study\n\nExclusion Criteria:\n\n1. Remaining life expectancy is less than 1 year\n2. Subjects with known hypersensitivity or contraindication to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor\n3. In case the other researcher judges that it is inappropriate to participate in this study (pregnant women, the elderly, etc.)'}, 'identificationModule': {'nctId': 'NCT05658250', 'briefTitle': 'CREATE Trial, Prospective, Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Feasibility of CRE8 Polymer-free Amphilimus-eluting sTEnt in Patients With Diffuse Long Lesions (CREATE Trial): Prospective, Observational Study', 'orgStudyIdInfo': {'id': '9-2021-0093'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CRE8 polymer-free Amphilimus-eluting stent, Cre8 evo stent', 'type': 'DEVICE', 'description': 'Percutaneous coronary intervention using a Cre8 stent, Cre8 evo stent for long lesions'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16995', 'city': 'Yongin', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Yongin Severance Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dio', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Deok-Kyu Cho', 'investigatorAffiliation': 'Yonsei University'}}}}