Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT00928356
Status:
COMPLETED
Last Update Posted:
2020-05-11
First Post:
2009-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Single Center Clinical Evaluation of Same Sitting Hybrid Revascularization: Robotic Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention for the Treatment of Coronary Artery Disease
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-07', 'studyFirstSubmitDate': '2009-06-23', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of this feasibility study is a 30-day composite of major adverse clinical events including death, repeat revascularization, stroke and/or myocardial infarction.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'One-year composite clinical event endpoints of major clinical events. Comparative analysis of consecutive patients undergoing off pump CABG with standard thoracotomy during study period.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Robotic Coronary Artery Bypass Surgery', 'Percutaneous Coronary Intervention', 'Hybrid Coronary Revascularization'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.pinnaclehealth.org', 'label': 'Pinnacle Health Cardiovascular Institute'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the safety and effectiveness of same sitting, simultaneous hybrid robotic assisted coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in the treatment of obstructive multivessel coronary artery disease. A secondary objective is the assessment and standardization of optimal operator techniques and comparative study of patients undergoing CABG during study period.', 'detailedDescription': 'The study population will consist of patients with multivessel coronary artery disease requiring CABG with suitable anatomy for combination CABG and PCI of non-bypassed arteries.\n\nThe primary endpoint of this feasibility study is a 30-day composite of major adverse clinical events including death, repeat revascularization, stroke and/or myocardial infarction.\n\nThe secondary endpoints include:\n\n1. Successful completion of same sitting CABG and coronary stent procedure\n2. Successful completion of CABG and PCI during single hospitalization\n3. Achievement of complete revascularization\n4. Patency of the LIMA and stented vessels as determined by coronary angiography at time of procedures or prior to discharge and by cardiac Computed Tomographic Angiography (CTA) or coronary angiography at 1 year.\n5. Stent thrombosis at 24 hours (acute), 30 days (sub acute), and 1 year (late)\n6. One-year composite clinical event endpoints of major clinical events including death, repeat revascularization, myocardial infarction, and freedom from angina\n7. Comparative analysis of hospital, 30 day, and 1 year events of hybrid CABG patients compared to consecutive patients undergoing off pump CABG with standard thoracotomy during study period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Requirement for CABG\n* Anatomy and body habitus suitable for Robotic CABG\n* Requirement of revascularization of arteries amendable for PCI but not accessable by Robotic CABG\n\nExclusion Criteria:\n\n* Need for emergent CABG'}, 'identificationModule': {'nctId': 'NCT00928356', 'briefTitle': 'A Single Center Clinical Evaluation of Same Sitting Hybrid Revascularization: Robotic Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention for the Treatment of Coronary Artery Disease', 'organization': {'class': 'NETWORK', 'fullName': 'Pinnacle Health Cardiovascular Institute'}, 'officialTitle': 'A Single Center Clinical Evaluation of Same Sitting Hybrid Revascularization: Robotic Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention for the Treatment of Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'Same Sitting Robotic CABG/PCI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hybrid CABG/PCI', 'description': 'Patients undergo hybrid, same sitting CABG/PCI as described.', 'interventionNames': ['Procedure: Hybrid CABG/PCI']}, {'type': 'OTHER', 'label': 'Off-pump CABG', 'description': 'Standard of Care Off Pump CABG', 'interventionNames': ['Procedure: Off Pump CABG']}], 'interventions': [{'name': 'Hybrid CABG/PCI', 'type': 'PROCEDURE', 'description': 'Same sitting hybrid, robotic CABG/PCI', 'armGroupLabels': ['Hybrid CABG/PCI']}, {'name': 'Off Pump CABG', 'type': 'PROCEDURE', 'description': 'Standard of Care Off Pump CABG', 'armGroupLabels': ['Off-pump CABG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17011', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Pinnacle Harrisburg', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}], 'overallOfficials': [{'name': 'William Bachinsky, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pinnacle Health Cardiovascular Institute, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pinnacle Health Cardiovascular Institute', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}