Impact of Aspiration Thrombectomy During Carotid Stenting

Carotid Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01550835
• Other study ID #: EV-10322
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2012
• Last updated: April 17, 2015
• Start date: February 2012

Study information

• Verified date: April 2015
• Source: Fogarty Clinical Research Inc.
• Contact: Betty deBettencourt, RN
• Phone: 650-962-4566
• Email: betty.debettencourt[@]fogartyinstitute.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

Device:
• Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
Standard of care use of an embolic protection device
• Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
Aspiration thrombectomy following stent deployment and prior to embolic protection device removal

Locations

Country	Name	City	State
United States	El Camino Hospital	Mountain View	California
United States	Northern Michigan Regional Hospital	Petoskey	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
Fogarty Clinical Research Inc.	Abbott Vascular, Helen Kay Foundation, Northern Michigan Hospital Foundation's Louis A. and Sally Cannon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of new, ischemic foci	Foci of restricted diffusion will be classified by their number, location, and size	18-48 hours post procedure	No
Secondary	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	No