Impact of Aspiration Thrombectomy During Carotid Stenting

Fogarty Clinical Research

Status: Unknown

Conditions: Carotid Artery Stenosis

Treatments: Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01550835

EV-10322

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Distal Embolic Protection Only

Experimental group

Description:

Carotid stenting with distal embolic protection only

Treatment:

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

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

Distal embolic protection and aspiration thrombectomy

Active Comparator group

Description:

Aspiration thrombectomy following stent deployment and prior to removal of distal embolic protection

Treatment:

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

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