Impact of Aspiration Thrombectomy During Carotid Stenting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Aspiration Thrombectomy During Carotid Stenting on New Ischemic Lesions Identified by Diffusion-Weighted Magnetic Resonance Imaging

Conditions
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Carotid Artery Stenosis

Intervention / Treatment
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* Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
* Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distal Embolic Protection Only<br>Carotid stenting with distal embolic protection only | Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)<br>* Standard of care use of an embolic protection device<br>|
| Active Comparator: Distal embolic protection and aspiration thrombectomy<br>Aspiration thrombectomy following stent deployment and prior to removal of distal embolic protection | Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)<br>* Aspiration thrombectomy following stent deployment and prior to embolic protection device removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new, ischemic foci | Foci of restricted diffusion will be classified by their number, location, and size | 18-48 hours post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic zone area | Maximum size of new, ipsilateral,ischemic foci on post-carotid stenting diffusion-weighted MRI of the brain | 18-48 hours post stenting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptomatic carotid artery stenosis