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Impact of Aspiration Thrombectomy During Carotid Stenting

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ClinicalTrials.gov Identifier: NCT01550835
Recruitment Status : Unknown
Verified April 2015 by James Joye, Fogarty Clinical Research Inc..
Recruitment status was:  Recruiting
First Posted : March 12, 2012
Last Update Posted : April 21, 2015
Sponsor:
Collaborators:
Abbott Medical Devices
Helen Kay Foundation
Northern Michigan Hospital Foundation's Louis A. and Sally Cannon
Information provided by (Responsible Party):
James Joye, Fogarty Clinical Research Inc.

Tracking Information
First Submitted Date  ICMJE March 1, 2012
First Posted Date  ICMJE March 12, 2012
Last Update Posted Date April 21, 2015
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
Number of new, ischemic foci [ Time Frame: 18-48 hours post procedure ]
Foci of restricted diffusion will be classified by their number, location, and size
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01550835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
Ischemic zone area [ Time Frame: 18-48 hours post stenting ]
Maximum size of new, ipsilateral,ischemic foci on post-carotid stenting diffusion-weighted MRI of the brain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Aspiration Thrombectomy During Carotid Stenting
Official Title  ICMJE Impact of Aspiration Thrombectomy During Carotid Stenting on New Ischemic Lesions Identified by Diffusion-Weighted Magnetic Resonance Imaging
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Carotid Artery Stenosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 7, 2012)
80
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01550835
Other Study ID Numbers  ICMJE EV-10322
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James Joye, Fogarty Clinical Research Inc.
Study Sponsor  ICMJE Fogarty Clinical Research Inc.
Collaborators  ICMJE
  • Abbott Medical Devices
  • Helen Kay Foundation
  • Northern Michigan Hospital Foundation's Louis A. and Sally Cannon
Investigators  ICMJE
Principal Investigator: James Joye, DO Fogarty Clinical Research Inc.
PRS Account Fogarty Clinical Research Inc.
Verification Date April 2015

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