A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting

Not Applicable

Completed

• Conditions: Carotid Artery Occlusive Disease
• Interventions: Procedure: Carotid endarterectomy vs. carotid stenting

• Registration Number: NCT02220595
• Lead Sponsor: Baylor College of Medicine

Brief Summary

This study compares cognitive function after carotid endarterectomy and stenting.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2014-08
• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-18
• Last Update Submitted: 2014-08-18
• Study First Posted: 2014-08-20
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Read More

Exclusion Criteria

• Contraindication for carotid endarterectomy or stenting

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carotid endarterectomy	Carotid endarterectomy vs. carotid stenting	Carotid artery endarterectomy for treatment of carotid artery stenosis
Carotid stenting	Carotid endarterectomy vs. carotid stenting	Carotid artery stenting for treatment of carotid artery stenosis

Primary Outcome Measures

Name	Time	Method
Difference in RAVLT score	Six weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Michael E. Debakey VAMC; 🇺🇸 Houston, Texas, United States