Impact of Aspiration Thrombectomy During Carotid Stenting

Status unconfirmed · Not applicable

Conditions studied: Carotid Artery Stenosis

In brief

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.

Key facts

Study ID

NCT01550835

Run by

Fogarty Clinical Research Inc.

People needed

80

Starts

2012-02-01

Last updated by the study team

2015-04-21

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• El Camino Hospital — Mountain View, California, United States (enrolling)
• Northern Michigan Regional Hospital — Petoskey, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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