Impact of Aspiration Thrombectomy During Carotid Stenting

Not Applicable

• Conditions: Carotid Artery Stenosis

• Registration Number: NCT01550835
• Lead Sponsor: Fogarty Clinical Research Inc.

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-21
• Primary Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of new, ischemic foci	18-48 hours post procedure	Foci of restricted diffusion will be classified by their number, location, and size

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

El Camino Hospital; 🇺🇸 Mountain View, California, United States

Northern Michigan Regional Hospital; 🇺🇸 Petoskey, Michigan, United States