Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-07 @ 7:02 AM
Study NCT ID:
NCT00975858
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2009-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Comparison of Stenting Versus Off-pump Coronary Bypass Surgery
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}, {'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2001-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-14', 'studyFirstSubmitDate': '2009-09-11', 'studyFirstSubmitQcDate': '2009-09-11', 'lastUpdatePostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Events', 'timeFrame': '7.5 years'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '7.5 years'}, {'measure': 'Neurocognitive outcome', 'timeFrame': '7.5 years'}, {'measure': 'Cost effectiveness', 'timeFrame': '7.5 years'}, {'measure': 'Angiographical patency of revascularization', 'timeFrame': '7.5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Symptomatic Coronary Artery Disease Patients'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '14656913', 'type': 'RESULT', 'citation': 'Eefting F, Nathoe H, van Dijk D, Jansen E, Lahpor J, Stella P, Suyker W, Diephuis J, Suryapranata H, Ernst S, Borst C, Buskens E, Grobbee D, de Jaegere P. Randomized comparison between stenting and off-pump bypass surgery in patients referred for angioplasty. Circulation. 2003 Dec 9;108(23):2870-6. doi: 10.1161/01.CIR.0000100723.50363.2C. Epub 2003 Dec 1.'}]}, 'descriptionModule': {'briefSummary': 'The randomized comparison of two strategies in coronary revascularization: bypass surgery without the use of a heart lung machine and coronary stenting procedure.\n\nThe comparison comprised the occurrence of cardiac adverse events after the procedure. In addition, costs, cognitive outcomes and angiography were assessed.', 'detailedDescription': 'Coronary artery bypass surgery with use of the heart lung machine (on-pump surgery), is associated with the risk of peri-operative complications such as death, stroke, myocardial infarction, neurocognitive decline, and extended hospitalization. Bypass surgery on the beating heart without the use of the heart lung machine (off-pump surgery) has been reintroduced in clinical practice in order to reduce these complications. The Octopus cardiac wall stabilizer, developed at the UMC Utrecht, facilitates the safe construction of the grafts during the off-pump procedure. The expected advantages of off-pump surgery e.g. less-invasiveness, complete arterial revascularization, faster recovery and lower costs were the basis for the Octostent trial. We hypothesized that the off-pump surgical technique might offer an alternative for angioplasty with bare-metal stent-implantation.\n\nThe current study was designed as a randomized controlled multicenter trial comparing two strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with coronary artery disease referred for PCI in which both Off Pump Coronary Bypass surgery and PCI were deemed technically feasible\n\nExclusion Criteria:\n\n* a history of CABG or stenting\n* emergency or concomitant major surgery\n* Q-wave myocardial infarction in the last six weeks\n* inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT00975858', 'acronym': 'OCTOSTENT', 'briefTitle': 'Long-term Comparison of Stenting Versus Off-pump Coronary Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'A Randomized Comparison of Long-term Clinical , Neurocognitive, Angiographical and Health-costs, After Stenting Versus Off-pump Coronary Bypass Surgery in Patients With Symptomatic Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'WOM protocol 98/009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Percutaneous Coronary Intervention', 'interventionNames': ['Procedure: Coronary Revascularization']}, {'type': 'EXPERIMENTAL', 'label': 'Off Pump Coronary Artery Bypass Surgery', 'interventionNames': ['Procedure: Coronary Revascularization']}], 'interventions': [{'name': 'Coronary Revascularization', 'type': 'PROCEDURE', 'otherNames': ['Stenting', 'PCI', 'OPCAB', 'MICAB'], 'description': 'revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease', 'armGroupLabels': ['Off Pump Coronary Artery Bypass Surgery', 'Percutaneous Coronary Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Hendrik M Nathoe, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Antonius Hospital', 'class': 'OTHER'}, {'name': 'Isala', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'JJ Regiel, MD / HM Nathoe, MD,PhD', 'oldOrganization': 'UMC Utrecht'}}}}