Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 11:52 AM
Study NCT ID:
NCT01559350
Status:
TERMINATED
Last Update Posted:
2019-04-05
First Post:
2012-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Graft Patency Analysis of the Right Coronary Artery System
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_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'Poor recruiting rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2012-03-20', 'lastUpdatePostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Graft occlusion', 'timeFrame': 'one year', 'description': 'Coronary CT follow up at discharge, 1, 5 and 10 years postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['OPCAB'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The ideal grafts for the right coronary artery system in coronary artery bypass surgery remain controversial. The objective of this study is to compare the long-term patency of a right gastroepiploic artery and a saphenous vein graft used for revascularization of the right coronary artery system in off pump coronary artery bypass surgery and to analyze the long-term clinical outcomes.\n\nTotal 224 patients will be enrolled according to the randomization protocol.\n\nCheck list\n\n1. Laboratories\n2. Quantitative coronary analysis (preoperative)\n3. Major adverse cardiac and cerebrovascular event\n4. coronary CT (coronary angiography if needed) at discharge, 1, 5, 10 years postoperatively\n5. Echocardiogram\n\n5\\. Cardiac enzyme', 'detailedDescription': 'The ideal bypass conduit for the right coronary artery remains a subject of intense controversy. A variety of grafts and configurations are used: the right gastroepiploic artery,the right internal thoracic artery in situ or in a Y-graft configuration,the free radial artery implanted into the aorta or the left internal thoracic artery, and the saphenous vein graft. The influence of the type of graft to the right coronary artery system on clinical results remains poorly documented, and the complementary conduit of choice to this system has yet to be determined. No superior long-term patency rate for any of these grafts to the RCA has been clearly established. We have used a saphenous vein and a right gastroepiploic artery for the right coronary artery system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who undergo OPCAB for triple vessel disease at Samsung Medical Center are enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Angiographic evidence of severe coronary stenosis on the right coronary territory\n* Elective surgery\n* Isolated off pump CABG\n* Age \\< 75 years and life expectancy \\> 5 years\n* Preoperative RGEA diameter \\> 1.5mm\n* Normal left ventricular function\n\nExclusion Criteria:\n\n* History of upper abdomen surgery\n* History of upper GI bleeding\n* Active gastric or duodenal ulcer\n* Body mass index \\> 35kg/m2\n* Redo surgery\n* Presence of varicose vein\n* Contraindication for CABG such as malignancy or liver cirrhosis\n* Other configuration than RGEA to RCA territory or SVG to RCA territory'}, 'identificationModule': {'nctId': 'NCT01559350', 'briefTitle': 'Graft Patency Analysis of the Right Coronary Artery System', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Graft Patency of the Right Coronary Artery System in OPCAB: Saphenous Vein Graft Versus Right Gastroepiploic Artery', 'orgStudyIdInfo': {'id': '2011-11-065'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RGEA group', 'description': 'A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB', 'interventionNames': ['Procedure: A right gastroepiploic artery in situ grafting']}, {'label': 'SVG group', 'description': 'A saphenous vein grafting in the right coronary artery system during OPCAB', 'interventionNames': ['Procedure: A saphenous vein grafting']}], 'interventions': [{'name': 'A right gastroepiploic artery in situ grafting', 'type': 'PROCEDURE', 'description': 'A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB', 'armGroupLabels': ['RGEA group']}, {'name': 'A saphenous vein grafting', 'type': 'PROCEDURE', 'description': 'A saphenous vein grafting in the right coronary artery system during OPCAB', 'armGroupLabels': ['SVG group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young Tak Lee, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}