A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting

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

Official Title
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A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting

Conditions
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Carotid Artery Occlusive Disease

Intervention / Treatment
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* Procedure: Carotid endarterectomy vs. carotid stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Carotid artery occlusive disease, asymptomatic greater than 80% with CTA or carotid duplex Exclusion Criteria: Contraindication for carotid endarterectomy or stenting

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carotid stenting<br>Carotid artery stenting for treatment of carotid artery stenosis | Procedure: Carotid endarterectomy vs. carotid stenting<br> <br> |
| Active Comparator: Carotid endarterectomy<br>Carotid artery endarterectomy for treatment of carotid artery stenosis | Procedure: Carotid endarterectomy vs. carotid stenting<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in RAVLT score |  | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive tests for attention, memory, processing speed, mood, motor function, visual-spatial skills, executive functioning |  | Six weeks and six months | 
| Cognitive tests of attention | Comparison in cognitive tests for attention between carotid endarterectomy and stenting | Six weeks | 
| Cognitive tests for memory | Comparison in cognitive tests for memory between carotid endarterectomy and stenting | Six weeks | 
| Cognitive tests for processing speed | Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting | Six weeks | 
| Cognitive tests of mood | Comparison in cognitive tests for mood between carotid endarterectomy and stenting | Six weeks | 
| Tests of motor function | Comparison in cognitive tests for motor function between carotid endarterectomy and stenting | Six weeks | 
| Cognitive tests of visual-spatial skills | Comparison in cognitive tests of visual-spatial skills between carotid endarterectomy and stenting | Six weeks | 
| Cognitive tests of executive functioning | Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting | Six weeks | 
| Cognitive tests of attention | Comparison in cognitive tests for attention between carotid endarterectomy and stenting | Six months | 
| Cognitive tests of memory | Comparison in cognitive tests for memory between carotid endarterectomy and stenting | Six weeks | 
| Cognitive tests of processing speed | Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting | Six months | 
| Cognitive tests of mood | Comparison in cognitive tests for mood between carotid endarterectomy and stenting | Six months | 
| Tests of motor function | Comparison in cognitive tests for motor function between carotid endarterectomy and stenting | Six months | 
| Cognitive tests of visual-spatial skills | Comparison in cognitive tests for visual-spatial skills between carotid endarterectomy and stenting | Six months | 
| Cognitive tests of executive functioning | Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting | Six months | 
| Difference in new ischemic infarcts in Diffusion - weighted MRI | Difference in new ischemic infarcts in Diffusion - weighted MRI | Six weeks | 
| Difference in new ischemic infarcts in Diffusion - weighted MRI | Difference in new ischemic infarcts in Diffusion - weighted MRI | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stenting, Endarterectomy, Cognition