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

March 1, 2012
April 18, 2014
February 2012
February 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01550835 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Carotid Artery Stenosis
  • 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
  • Experimental: Distal Embolic Protection Only
    Carotid stenting with distal embolic protection only
    Intervention: Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
  • Active Comparator: Distal embolic protection and aspiration thrombectomy
    Aspiration thrombectomy following stent deployment and prior to removal of distal embolic protection
    Intervention: Device: Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
February 2016   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact: Betty deBettencourt, RN 650-962-4566 betty.debettencourt@fogartyinstitute.org
United States
 
NCT01550835
EV-10322
No
James Joye, Fogarty Clinical Research Inc.
Fogarty Clinical Research Inc.
  • Abbott Vascular
  • Helen Kay Foundation
  • Northern Michigan Hospital Foundation's Louis A. and Sally Cannon
Principal Investigator: James Joye, DO Fogarty Clinical Research Inc.
Fogarty Clinical Research Inc.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP