Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-22 @ 2:47 PM
Study NCT ID:
NCT01550835
Status:
UNKNOWN
Last Update Posted:
2015-04-21
First Post:
2012-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Aspiration Thrombectomy During Carotid Stenting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-17', 'studyFirstSubmitDate': '2012-03-01', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of new, ischemic foci', 'timeFrame': '18-48 hours post procedure', 'description': 'Foci of restricted diffusion will be classified by their number, location, and size'}], 'secondaryOutcomes': [{'measure': 'Ischemic zone area', 'timeFrame': '18-48 hours post stenting', 'description': 'Maximum size of new, ipsilateral,ischemic foci on post-carotid stenting diffusion-weighted MRI of the brain'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Symptomatic carotid artery stenosis'], 'conditions': ['Carotid Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether aspiration thrombectomy following carotid stent deployment will reduce the number of procedure related signals as identified by diffusion weighted MRI of the brain.', 'detailedDescription': 'Studies have demonstrated that carotid artery stenting is a safe and effective alternative to carotid endarterectomy for high or standard risk patients with symptomatic stenosis. Despite the routine use of embolic protection devices, numerous studies have shown that carotid stenting is associated with a higher degree of intracranial emboli by diffusion-weighted MRI of the brain. A potential solution to minimize this effect is the use of aspiration prior to distal embolic protection removal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICA stenosis greater than 50 percent by carotid angiography\n* Documented hemispheric ischemic stroke, TIA, amaurosis fugax, or retinal stroke in the last six months ipsilateral to the stented lesion\n\nExclusion Criteria:\n\n* Subject less than 40 years of age\n* Pregnant subjects\n* Asymptomatic carotid stenosis\n* Total occlusion of target carotid artery\n* Inability to deploy distal protection device or stent in target vessel\n* Allergy to both aspirin and approved thienopyridine anti-platelet drugs (clopidogrel/ticlopidine)\n* Multiple carotid stenoses in same vessel that cannot be covered by single stent\n* Ipsilateral intracranial stenosis requiring treatment\n* Isolated common carotid stenosis\n* Stenosis less than 50 percent by angiography\n* Chronic or paroxysmal atrial fibrillation not treated with warfarin or dabigatran.\n* Life expectancy less than 30 days\n* Active bleeding diathesis\n* Suspected Myocardial Infarction within 72 hours prior to carotid stenting\n* Presence of intracranial tumor arteriovenous malformations or aneurysm requiring treatment\n* Inability to undergo DWMRI\n* Unwillingness to participate or provide consent\n* Subjects using a legally authorized representative for consent for participation\n* Concurrently enrolled in another study\n* Stroke, TIA, amaurosis fugax ipsilateral to the treated lesion more than 6 months from randomization\n* Occlusive or critical ilio-femoral disease that precludes safe femoral access to the aortic arch\n* Severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries\n* Prior large stroke, multiple lacunar infarcts, or dementia\n* Stenosis that contain visible thrombus'}, 'identificationModule': {'nctId': 'NCT01550835', 'briefTitle': 'Impact of Aspiration Thrombectomy During Carotid Stenting', 'organization': {'class': 'OTHER', 'fullName': 'Fogarty Clinical Research Inc.'}, 'officialTitle': 'Impact of Aspiration Thrombectomy During Carotid Stenting on New Ischemic Lesions Identified by Diffusion-Weighted Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'EV-10322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Distal Embolic Protection Only', 'description': 'Carotid stenting with distal embolic protection only', 'interventionNames': ['Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Distal embolic protection and aspiration thrombectomy', 'description': 'Aspiration thrombectomy following stent deployment and prior to removal of distal embolic protection', 'interventionNames': ['Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)']}], 'interventions': [{'name': 'Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)', 'type': 'DEVICE', 'description': 'Standard of care use of an embolic protection device', 'armGroupLabels': ['Distal Embolic Protection Only']}, {'name': 'Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)', 'type': 'DEVICE', 'description': 'Aspiration thrombectomy following stent deployment and prior to embolic protection device removal', 'armGroupLabels': ['Distal embolic protection and aspiration thrombectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Betty deBettencourt, RN', 'role': 'CONTACT', 'email': 'betty.debettencourt@fogartyinstitute.org', 'phone': '650-962-4566'}, {'name': 'James Joye, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'El Camino Hospital', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '49770', 'city': 'Petoskey', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Lalonde, RN', 'role': 'CONTACT', 'email': 'jlalonde@cvrcnm.com', 'phone': '231-487-9185'}, {'name': 'Jason Ricci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northern Michigan Regional Hospital', 'geoPoint': {'lat': 45.37334, 'lon': -84.95533}}], 'centralContacts': [{'name': 'Betty deBettencourt, RN', 'role': 'CONTACT', 'email': 'betty.debettencourt@fogartyinstitute.org', 'phone': '650-962-4566'}], 'overallOfficials': [{'name': 'James Joye, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fogarty Clinical Research Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fogarty Clinical Research Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, {'name': 'Helen Kay Foundation', 'class': 'UNKNOWN'}, {'name': "Northern Michigan Hospital Foundation's Louis A. and Sally Cannon", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Medical Officer', 'investigatorFullName': 'James Joye', 'investigatorAffiliation': 'Fogarty Clinical Research Inc.'}}}}