Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.

University Ghent

Status: Completed

Conditions: Carotid Stenosis

Treatments: Procedure: Detection of peri-operative embolization; Procedure: Neurocognitive functions; Procedure: Validation results; Procedure: Carotid endarterectomy (CEA); Procedure: Carotid stenting (CAS); Procedure: Levels of biomarkers

Study type: Interventional

Funder types: Other

Identifiers

NCT01337128

2010/819

Details and patient eligibility

About

In this prospective study, patients with carotid stenosis will be randomly assigned to one of the two surgical procedures (carotid endarterectomy (CEA) and carotid stenting (CAS)). Pre- and postoperative neuropsychological functions, levels of several biomarkers and intraoperative embolization load will be examined. In a subgroup of patients, MRI-data will also be gathered. The mix of these data will allow us to answer several questions regarding the absence or presence of preoperative impairments, postoperative changes in cognitive performance and possible differences between CEA and CAS regarding postoperative neuropsychological functions. The use of a matched control group and implementation of a long term follow-up will contribute to the uniqueness of this study. It will meet several flaws of previous studies and will complete the ongoing randomized studies comparing CEA and CAS that are lacking neuropsychological data.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Carotid endarterectomy (CEA)

Experimental group

Description:

Patients with carotid stenosis who are randomly assigned to a carotid endarterectomy.

Treatment:

Procedure: Carotid endarterectomy (CEA)

Procedure: Detection of peri-operative embolization

Procedure: Neurocognitive functions

Procedure: Validation results

Procedure: Levels of biomarkers

Carotid Stenting (CAS)

Experimental group

Description:

Patients with carotid stenosis who are randomly assigned to a carotid stenting.

Treatment:

Procedure: Detection of peri-operative embolization

Procedure: Neurocognitive functions

Procedure: Carotid stenting (CAS)

Procedure: Validation results

Procedure: Levels of biomarkers

matched control group

No Intervention group

Description:

Matched control group.