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A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02220595
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Panos Kougias, Baylor College of Medicine

Brief Summary:
This study compares cognitive function after carotid endarterectomy and stenting.

Condition or disease Intervention/treatment Phase
Carotid Artery Occlusive Disease Procedure: Carotid endarterectomy vs. carotid stenting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting
Study Start Date : April 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: Carotid stenting
Carotid artery stenting for treatment of carotid artery stenosis
Procedure: Carotid endarterectomy vs. carotid stenting
Active Comparator: Carotid endarterectomy
Carotid artery endarterectomy for treatment of carotid artery stenosis
Procedure: Carotid endarterectomy vs. carotid stenting



Primary Outcome Measures :
  1. Difference in RAVLT score [ Time Frame: Six weeks ]

Secondary Outcome Measures :
  1. Cognitive tests for attention, memory, processing speed, mood, motor function, visual-spatial skills, executive functioning [ Time Frame: Six weeks and six months ]
  2. Cognitive tests of attention [ Time Frame: Six weeks ]
    Comparison in cognitive tests for attention between carotid endarterectomy and stenting

  3. Cognitive tests for memory [ Time Frame: Six weeks ]
    Comparison in cognitive tests for memory between carotid endarterectomy and stenting

  4. Cognitive tests for processing speed [ Time Frame: Six weeks ]
    Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting

  5. Cognitive tests of mood [ Time Frame: Six weeks ]
    Comparison in cognitive tests for mood between carotid endarterectomy and stenting

  6. Tests of motor function [ Time Frame: Six weeks ]
    Comparison in cognitive tests for motor function between carotid endarterectomy and stenting

  7. Cognitive tests of visual-spatial skills [ Time Frame: Six weeks ]
    Comparison in cognitive tests of visual-spatial skills between carotid endarterectomy and stenting

  8. Cognitive tests of executive functioning [ Time Frame: Six weeks ]
    Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting

  9. Cognitive tests of attention [ Time Frame: Six months ]
    Comparison in cognitive tests for attention between carotid endarterectomy and stenting

  10. Cognitive tests of memory [ Time Frame: Six weeks ]
    Comparison in cognitive tests for memory between carotid endarterectomy and stenting

  11. Cognitive tests of processing speed [ Time Frame: Six months ]
    Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting

  12. Cognitive tests of mood [ Time Frame: Six months ]
    Comparison in cognitive tests for mood between carotid endarterectomy and stenting

  13. Tests of motor function [ Time Frame: Six months ]
    Comparison in cognitive tests for motor function between carotid endarterectomy and stenting

  14. Cognitive tests of visual-spatial skills [ Time Frame: Six months ]
    Comparison in cognitive tests for visual-spatial skills between carotid endarterectomy and stenting

  15. Cognitive tests of executive functioning [ Time Frame: Six months ]
    Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting

  16. Difference in new ischemic infarcts in Diffusion - weighted MRI [ Time Frame: Six weeks ]
    Difference in new ischemic infarcts in Diffusion - weighted MRI

  17. Difference in new ischemic infarcts in Diffusion - weighted MRI [ Time Frame: Six months ]
    Difference in new ischemic infarcts in Diffusion - weighted MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Carotid artery occlusive disease, asymptomatic greater than 80% with CTA or carotid duplex

Exclusion Criteria:

  • Contraindication for carotid endarterectomy or stenting

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220595


Locations
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United States, Texas
Michael E. Debakey VAMC
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
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Responsible Party: Panos Kougias, Chief, Vascular Surgery, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02220595    
Other Study ID Numbers: H - 22797
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by Panos Kougias, Baylor College of Medicine:
Stenting
Endarterectomy
Cognition