Impact of Aspiration Thrombectomy During Carotid Stenting

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

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.

Study Overview

• Status: Unknown
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA); Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94040
      • Recruiting
      • El Camino Hospital
      • Contact: Betty deBettencourt, RN; Phone Number: 650-962-4566; Email: betty.debettencourt@fogartyinstitute.org
      • Principal Investigator: James Joye, DO
  • Michigan
    • Petoskey, Michigan, United States, 49770
      • Recruiting
      • Northern Michigan Regional Hospital
      • Contact: Jennifer Lalonde, RN; Phone Number: 231-487-9185; Email: jlalonde@cvrcnm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Distal Embolic Protection Only; Carotid stenting with distal embolic protection only	Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA); Standard of care use of an embolic protection device; Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA); Aspiration thrombectomy following stent deployment and prior to embolic protection device removal
ACTIVE_COMPARATOR: Distal embolic protection and aspiration thrombectomy; Aspiration thrombectomy following stent deployment and prior to removal of distal embolic protection	Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA); Standard of care use of an embolic protection device; Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA); Aspiration thrombectomy following stent deployment and prior to embolic protection device removal

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fogarty Clinical Research Inc.
• Collaborators: Abbott Medical Devices; Helen Kay Foundation; Northern Michigan Hospital Foundation's Louis A. and Sally Cannon
• Investigators: Principal Investigator: James Joye, DO, Fogarty Clinical Research Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ANTICIPATED): February 1, 2016

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (ESTIMATE): March 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 17, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Symptomatic carotid artery stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: EV-10322