Impact of Aspiration Thrombectomy During Carotid Stenting

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Fogarty Clinical Research Inc.
Sponsor:
Collaborators:
Abbott Vascular
Helen Kay Foundation
Northern Michigan Hospital Foundation's Louis A. and Sally Cannon
Information provided by (Responsible Party):
James Joye, Fogarty Clinical Research Inc.
ClinicalTrials.gov Identifier:
NCT01550835
First received: March 1, 2012
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Carotid Artery Stenosis
Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Impact of Aspiration Thrombectomy During Carotid Stenting on New Ischemic Lesions Identified by Diffusion-Weighted Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Fogarty Clinical Research Inc.:

Primary Outcome Measures:
  • Number of new, ischemic foci [ Time Frame: 18-48 hours post procedure ] [ Designated as safety issue: No ]
    Foci of restricted diffusion will be classified by their number, location, and size


Secondary Outcome Measures:
  • Ischemic zone area [ Time Frame: 18-48 hours post stenting ] [ Designated as safety issue: No ]
    Maximum size of new, ipsilateral,ischemic foci on post-carotid stenting diffusion-weighted MRI of the brain


Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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)
Aspiration thrombectomy following stent deployment and prior to embolic protection device removal

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550835

Contacts
Contact: Betty deBettencourt, RN 650-962-4566 betty.debettencourt@fogartyinstitute.org

Locations
United States, California
El Camino Hospital Recruiting
Mountain View, California, United States, 94040
Contact: Betty deBettencourt, RN    650-962-4566    betty.debettencourt@fogartyinstitute.org   
Principal Investigator: James Joye, DO         
United States, Michigan
Northern Michigan Regional Hospital Recruiting
Petoskey, Michigan, United States, 49770
Contact: Jennifer Lalonde, RN    231-487-9185    jlalonde@cvrcnm.com   
Principal Investigator: Jason Ricci, MD         
Sponsors and Collaborators
Fogarty Clinical Research Inc.
Abbott Vascular
Helen Kay Foundation
Northern Michigan Hospital Foundation's Louis A. and Sally Cannon
Investigators
Principal Investigator: James Joye, DO Fogarty Clinical Research Inc.
  More Information

No publications provided

Responsible Party: James Joye, Chief Medical Officer, Fogarty Clinical Research Inc.
ClinicalTrials.gov Identifier: NCT01550835     History of Changes
Other Study ID Numbers: EV-10322
Study First Received: March 1, 2012
Last Updated: April 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Fogarty Clinical Research Inc.:
Symptomatic carotid artery stenosis

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 28, 2014