Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.
NCT ID: NCT01337128
Last Updated: 2021-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2011-04-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Carotid endarterectomy (CEA)
Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.
Carotid endarterectomy (CEA)
Carotid endarterectomy (CEA) will be performed on the patients
Neurocognitive functions
Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
Levels of biomarkers
Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
Detection of peri-operative embolization
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
Validation results
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
Carotid Stenting (CAS)
Patients with carotid stenosis who are randomly assigned to a carotid stenting.
Carotid stenting (CAS)
Carotid Stenting (CAS) will be performed on these patients.
Neurocognitive functions
Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
Levels of biomarkers
Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
Detection of peri-operative embolization
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
Validation results
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
matched control group
Matched control group.
No interventions assigned to this group
Interventions
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Carotid endarterectomy (CEA)
Carotid endarterectomy (CEA) will be performed on the patients
Carotid stenting (CAS)
Carotid Stenting (CAS) will be performed on these patients.
Neurocognitive functions
Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
Levels of biomarkers
Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
Detection of peri-operative embolization
A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
Validation results
On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Older than 80 years
* A history of psychiatric or neurological illness
* Severe alcohol of drug abuse
* Coronary artery bypass graft (CABG) less than a year ago.
18 Years
80 Years
ALL
Yes
Sponsors
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University Hospital, Ghent
OTHER
University Ghent
OTHER
Responsible Party
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Principal Investigators
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Frank Vermassen, Ph.D., M.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Guy Vingerhoets, Ph.D., Professor
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Other Identifiers
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2010/819
Identifier Type: -
Identifier Source: org_study_id