Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-25 @ 5:55 PM
Study NCT ID:
NCT03788369
Status:
RECRUITING
Last Update Posted:
2024-12-24
First Post:
2018-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2018-12-21', 'studyFirstSubmitQcDate': '2018-12-25', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a composite event of death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.', 'timeFrame': '5 years', 'description': 'Patients who have experienced any one of the following events are considered to have experienced the composite outcome: death, myocardial infarction, TVR(Target Vessel Revascularization), or stroke.'}], 'secondaryOutcomes': [{'measure': 'All death', 'timeFrame': '5 years'}, {'measure': 'Cardiac death', 'timeFrame': '5 years'}, {'measure': 'Myocardial infarction', 'timeFrame': '5 years'}, {'measure': 'a composite event of all death or myocardial infarction', 'timeFrame': '5 years'}, {'measure': 'a composite event of cardiac death or myocardial infarction', 'timeFrame': '5 years'}, {'measure': 'TVR(Target Vessel Revascularization)', 'timeFrame': '5 years'}, {'measure': 'TLR(Target Lesion Revascularization)', 'timeFrame': '5 years'}, {'measure': 'Stent thrombosis', 'timeFrame': '5 years', 'description': 'by an Academic Research Consortium (ARC) category'}, {'measure': 'Cerebrovascular event', 'timeFrame': '5 years'}, {'measure': 'Procedural success', 'timeFrame': '5 days', 'description': 'Procedural success is defined as \\< 30% final stenosis and the absence of in-hospital event including death, Q-wave myocardial infarction or urgent repeat revascularization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hybrid coronary revascularization'], 'conditions': ['Percutaneous Coronary Revascularization', 'Coronary Stenosis', 'Coronary Artery Disease Progression', 'Coronary Artery Bypass Grafting']}, 'descriptionModule': {'briefSummary': 'This study evaluated the effectiveness and safety of Hybrid Coronary Revascularization in real-world practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hybrid coronary revascularization due to multivessel coronary artery disease(must include left anterior descending artery)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20 and more\n* Hybrid coronary revascularization due to multivessel coronary artery disease(must include left anterior descending artery)\n* Written consent\n\nExclusion Criteria:\n\n* Previous CABG(coronary artery bypass graft)\n* Life expectancy ≤1 year'}, 'identificationModule': {'nctId': 'NCT03788369', 'acronym': 'HCR registry', 'briefTitle': 'Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization, a Non-randomized, Prospective, Open-label Registry in Real-world Practice', 'orgStudyIdInfo': {'id': 'AMCCV2018-12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multivessel coronary artery disease', 'description': 'must include left anterior descending artery', 'interventionNames': ['Procedure: Hybrid Coronary Revascularization']}], 'interventions': [{'name': 'Hybrid Coronary Revascularization', 'type': 'PROCEDURE', 'otherNames': ['HCR'], 'description': 'Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels.', 'armGroupLabels': ['Multivessel coronary artery disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-jung Park, MD', 'role': 'CONTACT', 'email': 'sjpark@amc.seoul.kr'}, {'name': 'Seung-jung Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Do-yoon Kang, MD', 'role': 'CONTACT', 'email': 'kdy1218@gmail.com', 'phone': '82-2-3010-1745'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}