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

Summary

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.

Conditions

• Carotid Stenosis

Interventions

PROCEDURE

Carotid endarterectomy (CEA)

Carotid endarterectomy (CEA) will be performed on the patients

PROCEDURE

Carotid stenting (CAS)

Carotid Stenting (CAS) will be performed on these patients.

PROCEDURE

Neurocognitive functions

Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.

PROCEDURE

Levels of biomarkers

Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.

PROCEDURE

Detection of peri-operative embolization

A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.

PROCEDURE

Validation results

On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.

Sponsors & Collaborators

• University Hospital, Ghent

  collaborator OTHER

• University Ghent

  lead OTHER

Principal Investigators

• Frank Vermassen, Ph.D., M.D. · University Hospital, Ghent

• Guy Vingerhoets, Ph.D., Professor · University Ghent

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2015-04-30

Completion

2015-09-30

Countries

• Belgium

Study Locations