Clinical trial NCT01550835: Impact of Aspiration Thrombectomy During Carotid Stenting
Official title: Impact of Aspiration Thrombectomy During Carotid Stenting on New Ischemic Lesions Identified by Diffusion-Weighted Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carotid Artery Stenosis
Keywords: Symptomatic carotid artery stenosis
Lead sponsor: Fogarty Clinical Research Inc.
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: Helen Kay Foundation
name: Northern Michigan Hospital Foundation's Louis A. and Sally Cannon
First posted: 2012-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of new, ischemic foci
timeFrame: 18-48 hours post procedure
Secondary outcomes:
measure: Ischemic zone area
timeFrame: 18-48 hours post stenting
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Petoskey
country: United States
facility: Northern Michigan Regional Hospital
state: Michigan
Study officials:
affiliation: Fogarty Clinical Research Inc.
name: James Joye, DO
role: PRINCIPAL_INVESTIGATOR
References: