<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02220595</url>
  </required_header>
  <id_info>
    <org_study_id>H - 22797</org_study_id>
    <nct_id>NCT02220595</nct_id>
  </id_info>
  <brief_title>A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting</brief_title>
  <official_title>A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares cognitive function after carotid endarterectomy and stenting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in RAVLT score</measure>
    <time_frame>Six weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests for attention, memory, processing speed, mood, motor function, visual-spatial skills, executive functioning</measure>
    <time_frame>Six weeks and six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests of attention</measure>
    <time_frame>Six weeks</time_frame>
    <description>Comparison in cognitive tests for attention between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests for memory</measure>
    <time_frame>Six weeks</time_frame>
    <description>Comparison in cognitive tests for memory between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests for processing speed</measure>
    <time_frame>Six weeks</time_frame>
    <description>Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests of mood</measure>
    <time_frame>Six weeks</time_frame>
    <description>Comparison in cognitive tests for mood between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tests of motor function</measure>
    <time_frame>Six weeks</time_frame>
    <description>Comparison in cognitive tests for motor function between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests of visual-spatial skills</measure>
    <time_frame>Six weeks</time_frame>
    <description>Comparison in cognitive tests of visual-spatial skills between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests of executive functioning</measure>
    <time_frame>Six weeks</time_frame>
    <description>Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests of attention</measure>
    <time_frame>Six months</time_frame>
    <description>Comparison in cognitive tests for attention between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests of memory</measure>
    <time_frame>Six weeks</time_frame>
    <description>Comparison in cognitive tests for memory between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests of processing speed</measure>
    <time_frame>Six months</time_frame>
    <description>Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests of mood</measure>
    <time_frame>Six months</time_frame>
    <description>Comparison in cognitive tests for mood between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tests of motor function</measure>
    <time_frame>Six months</time_frame>
    <description>Comparison in cognitive tests for motor function between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests of visual-spatial skills</measure>
    <time_frame>Six months</time_frame>
    <description>Comparison in cognitive tests for visual-spatial skills between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive tests of executive functioning</measure>
    <time_frame>Six months</time_frame>
    <description>Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in new ischemic infarcts in Diffusion - weighted MRI</measure>
    <time_frame>Six weeks</time_frame>
    <description>Difference in new ischemic infarcts in Diffusion - weighted MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in new ischemic infarcts in Diffusion - weighted MRI</measure>
    <time_frame>Six months</time_frame>
    <description>Difference in new ischemic infarcts in Diffusion - weighted MRI</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Carotid Artery Occlusive Disease</condition>
  <arm_group>
    <arm_group_label>Carotid stenting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Carotid artery stenting for treatment of carotid artery stenosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carotid endarterectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Carotid artery endarterectomy for treatment of carotid artery stenosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Carotid endarterectomy vs. carotid stenting</intervention_name>
    <arm_group_label>Carotid endarterectomy</arm_group_label>
    <arm_group_label>Carotid stenting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Carotid artery occlusive disease, asymptomatic greater than 80% with CTA or carotid&#xD;
             duplex&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication for carotid endarterectomy or stenting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Michael E. Debakey VAMC</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Panos Kougias</investigator_full_name>
    <investigator_title>Chief, Vascular Surgery</investigator_title>
  </responsible_party>
  <keyword>Stenting</keyword>
  <keyword>Endarterectomy</keyword>
  <keyword>Cognition</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02220595
org study id: H - 22797
nct id: NCT02220595
lead sponsor: 
has dmc: No
This study compares cognitive function after carotid endarterectomy and stenting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Difference in RAVLT score
time frame: Six weeks
measure: Cognitive tests for attention, memory, processing speed, mood, motor function, visual-spatial skills, executive functioning
time frame: Six weeks and six months
measure: Cognitive tests of attention
time frame: Six weeks
description: Comparison in cognitive tests for attention between carotid endarterectomy and stenting
measure: Cognitive tests for memory
time frame: Six weeks
description: Comparison in cognitive tests for memory between carotid endarterectomy and stenting
measure: Cognitive tests for processing speed
time frame: Six weeks
description: Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting
measure: Cognitive tests of mood
time frame: Six weeks
description: Comparison in cognitive tests for mood between carotid endarterectomy and stenting
measure: Tests of motor function
time frame: Six weeks
description: Comparison in cognitive tests for motor function between carotid endarterectomy and stenting
measure: Cognitive tests of visual-spatial skills
time frame: Six weeks
description: Comparison in cognitive tests of visual-spatial skills between carotid endarterectomy and stenting
measure: Cognitive tests of executive functioning
time frame: Six weeks
description: Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting
measure: Cognitive tests of attention
time frame: Six months
description: Comparison in cognitive tests for attention between carotid endarterectomy and stenting
measure: Cognitive tests of memory
time frame: Six weeks
description: Comparison in cognitive tests for memory between carotid endarterectomy and stenting
measure: Cognitive tests of processing speed
time frame: Six months
description: Comparison in cognitive tests for processing speed between carotid endarterectomy and stenting
measure: Cognitive tests of mood
time frame: Six months
description: Comparison in cognitive tests for mood between carotid endarterectomy and stenting
measure: Tests of motor function
time frame: Six months
description: Comparison in cognitive tests for motor function between carotid endarterectomy and stenting
measure: Cognitive tests of visual-spatial skills
time frame: Six months
description: Comparison in cognitive tests for visual-spatial skills between carotid endarterectomy and stenting
measure: Cognitive tests of executive functioning
time frame: Six months
description: Comparison in cognitive tests for executive functioning between carotid endarterectomy and stenting
measure: Difference in new ischemic infarcts in Diffusion - weighted MRI
time frame: Six weeks
description: Difference in new ischemic infarcts in Diffusion - weighted MRI
measure: Difference in new ischemic infarcts in Diffusion - weighted MRI
time frame: Six months
description: Difference in new ischemic infarcts in Diffusion - weighted MRI
arm group label: Carotid stenting
arm group type: Experimental
description: Carotid artery stenting for treatment of carotid artery stenosis
arm group label: Carotid endarterectomy
arm group type: Active Comparator
description: Carotid artery endarterectomy for treatment of carotid artery stenosis
intervention type: Procedure
intervention name: Carotid endarterectomy vs. carotid stenting
arm group label: Carotid endarterectomy
arm group label: Carotid stenting
criteria: 
gender: All
minimum age: 30 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Panos Kougias
investigator title: Chief, Vascular Surgery