Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT02220595
Status:
COMPLETED
Last Update Posted:
2014-08-20
First Post:
2014-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-18', 'studyFirstSubmitDate': '2014-08-08', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in RAVLT score', 'timeFrame': 'Six weeks'}], 'secondaryOutcomes': [{'measure': 'Cognitive tests for attention, memory, processing speed, mood, motor function, visual-spatial skills, executive functioning', 'timeFrame': 'Six weeks and six months'}, {'measure': 'Cognitive tests of attention', 'timeFrame': 'Six weeks', 'description': 'Comparison in cognitive tests for attention between carotid endarterectomy and stenting'}, {'measure': 'Cognitive tests for memory', 'timeFrame': 'Six weeks', 'description': 'Comparison in cognitive tests for memory between carotid endarterectomy and stenting'}, {'measure': 'Cognitive tests for processing speed', 'timeFrame': 'Six weeks', 'description': 'Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting'}, {'measure': 'Cognitive tests of mood', 'timeFrame': 'Six weeks', 'description': 'Comparison in cognitive tests for mood between carotid endarterectomy and stenting'}, {'measure': 'Tests of motor function', 'timeFrame': 'Six weeks', 'description': 'Comparison in cognitive tests for motor function between carotid endarterectomy and stenting'}, {'measure': 'Cognitive tests of visual-spatial skills', 'timeFrame': 'Six weeks', 'description': 'Comparison in cognitive tests of visual-spatial skills between carotid endarterectomy and stenting'}, {'measure': 'Cognitive tests of executive functioning', 'timeFrame': 'Six weeks', 'description': 'Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting'}, {'measure': 'Cognitive tests of attention', 'timeFrame': 'Six months', 'description': 'Comparison in cognitive tests for attention between carotid endarterectomy and stenting'}, {'measure': 'Cognitive tests of memory', 'timeFrame': 'Six weeks', 'description': 'Comparison in cognitive tests for memory between carotid endarterectomy and stenting'}, {'measure': 'Cognitive tests of processing speed', 'timeFrame': 'Six months', 'description': 'Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting'}, {'measure': 'Cognitive tests of mood', 'timeFrame': 'Six months', 'description': 'Comparison in cognitive tests for mood between carotid endarterectomy and stenting'}, {'measure': 'Tests of motor function', 'timeFrame': 'Six months', 'description': 'Comparison in cognitive tests for motor function between carotid endarterectomy and stenting'}, {'measure': 'Cognitive tests of visual-spatial skills', 'timeFrame': 'Six months', 'description': 'Comparison in cognitive tests for visual-spatial skills between carotid endarterectomy and stenting'}, {'measure': 'Cognitive tests of executive functioning', 'timeFrame': 'Six months', 'description': 'Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting'}, {'measure': 'Difference in new ischemic infarcts in Diffusion - weighted MRI', 'timeFrame': 'Six weeks', 'description': 'Difference in new ischemic infarcts in Diffusion - weighted MRI'}, {'measure': 'Difference in new ischemic infarcts in Diffusion - weighted MRI', 'timeFrame': 'Six months', 'description': 'Difference in new ischemic infarcts in Diffusion - weighted MRI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stenting', 'Endarterectomy', 'Cognition'], 'conditions': ['Carotid Artery Occlusive Disease']}, 'descriptionModule': {'briefSummary': 'This study compares cognitive function after carotid endarterectomy and stenting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Carotid artery occlusive disease, asymptomatic greater than 80% with CTA or carotid duplex\n\nExclusion Criteria:\n\n* Contraindication for carotid endarterectomy or stenting'}, 'identificationModule': {'nctId': 'NCT02220595', 'briefTitle': 'A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting', 'orgStudyIdInfo': {'id': 'H - 22797'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carotid stenting', 'description': 'Carotid artery stenting for treatment of carotid artery stenosis', 'interventionNames': ['Procedure: Carotid endarterectomy vs. carotid stenting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carotid endarterectomy', 'description': 'Carotid artery endarterectomy for treatment of carotid artery stenosis', 'interventionNames': ['Procedure: Carotid endarterectomy vs. carotid stenting']}], 'interventions': [{'name': 'Carotid endarterectomy vs. carotid stenting', 'type': 'PROCEDURE', 'armGroupLabels': ['Carotid endarterectomy', 'Carotid stenting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Michael E. Debakey VAMC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Vascular Surgery', 'investigatorFullName': 'Panos Kougias', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}