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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01337128 |
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Date of registration:
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15/04/2011 |
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Primary sponsor: |
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Public title:
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Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.
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Scientific title:
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Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis. |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01337128 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Frank Vermassen, Ph.D. , M.D. |
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Address:
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Telephone:
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Email:
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Frank.Vermassen@ugent.be |
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Affiliation:
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Name:
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Maarten Plessers |
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Address:
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Telephone:
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Email:
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Maarten.Plessers@ugent.be |
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Affiliation:
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Name:
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Guy Vingerhoets, Ph.D. , Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ghent University |
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Name:
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Frank Vermassen, Ph.D. , M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ghent University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with carotid stenosis.
Exclusion Criteria:
- Significant medical conditions which affect neurocognitive functions (e.g. cancer,
epilepsy)
- 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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carotid Stenosis
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Intervention(s)
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Procedure: Carotid endarterectomy (CEA)
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Procedure: Carotid stenting (CAS)
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Procedure: Detection of peri-operative embolization
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Procedure: Levels of biomarkers
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Procedure: Neurocognitive functions
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Procedure: Validation results
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Primary Outcome(s)
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Post-operative neuropsychological state (1 year)
[Time Frame: after 1 year]
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Post-operative neuropsychological state (3 weeks)
[Time Frame: after 3 weeks]
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Post-operative neuropsychological state (6 months)
[Time Frame: after 6 months]
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Pre-operative neuropsychological state
[Time Frame: pre-operative]
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Secondary Outcome(s)
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Clinical neurological examination after 1 year
[Time Frame: after 1 year]
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Clinical neurological examination after 3 weeks
[Time Frame: after 3 weeks]
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Clinical neurological examination after 6 months
[Time Frame: after 6 months]
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Determination of cardiovascular risks after 1 year
[Time Frame: after 1 year]
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Determination of cardiovascular risks after 3 weeks
[Time Frame: after 3 weeks]
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Determination of cardiovascular risks after 6 months
[Time Frame: after 6 months]
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Determination of cardiovascular risks pre-operatively
[Time Frame: pre-operatively]
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Levels of biomarkers pre-operatively
[Time Frame: pre-operatively, intra-operative, after 2 hours, 6 hours and 24 hours]
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Peri-operative embolization
[Time Frame: Peri-operative]
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Validation results
[Time Frame: pre- and post-operative after 48 hours and 3 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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