NCT01337128

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-04-01
• Completion: 2015-09-01
• First posted: 2011-04-18
• Last updated: 2021-12-01

Locations

1 site across 1 country: Belgium