Carotid Artery Stenosis
Conditions
Keywords
Symptomatic carotid artery stenosis
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEmboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
Standard of care use of an embolic protection device
Sponsors
Abbott Medical Devices
Helen Kay Foundation
Northern Michigan Hospital Foundation's Louis A. and Sally Cannon
Fogarty Clinical Research Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ICA stenosis greater than 50 percent by carotid angiography * Documented hemispheric ischemic stroke, TIA, amaurosis fugax, or retinal stroke in the last six months ipsilateral to the stented lesion
Exclusion criteria
* Subject less than 40 years of age * Pregnant subjects * Asymptomatic carotid stenosis * Total occlusion of target carotid artery * Inability to deploy distal protection device or stent in target vessel * Allergy to both aspirin and approved thienopyridine anti-platelet drugs (clopidogrel/ticlopidine) * Multiple carotid stenoses in same vessel that cannot be covered by single stent * Ipsilateral intracranial stenosis requiring treatment * Isolated common carotid stenosis * Stenosis less than 50 percent by angiography * Chronic or paroxysmal atrial fibrillation not treated with warfarin or dabigatran. * Life expectancy less than 30 days * Active bleeding diathesis * Suspected Myocardial Infarction within 72 hours prior to carotid stenting * Presence of intracranial tumor arteriovenous malformations or aneurysm requiring treatment * Inability to undergo DWMRI * Unwillingness to participate or provide consent * Subjects using a legally authorized representative for consent for participation * Concurrently enrolled in another study * Stroke, TIA, amaurosis fugax ipsilateral to the treated lesion more than 6 months from randomization * Occlusive or critical ilio-femoral disease that precludes safe femoral access to the aortic arch * Severe atherosclerosis of the aortic arch or origin of the innominate or common carotid arteries * Prior large stroke, multiple lacunar infarcts, or dementia * Stenosis that contain visible thrombus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of new, ischemic foci | 18-48 hours post procedure | Foci of restricted diffusion will be classified by their number, location, and size |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ischemic zone area | 18-48 hours post stenting | Maximum size of new, ipsilateral,ischemic foci on post-carotid stenting diffusion-weighted MRI of the brain |
Countries
United States
Contacts
Primary ContactBetty deBettencourt, RN
Outcome results
None listed