Active — Not RecruitingNot Applicable

Comparison of Cerebral Oximetry and Neurological Status Testing in the Awake Patient in the Detection of Cerebral Ischemia During Carotid Endarterectomy

Serbia160 participantsStarted 2025-12-22

Plain-language summary

This randomized controlled study compares two methods of intraoperative cerebral ischemia monitoring during carotid endarterectomy performed under regional anesthesia: neurological testing in the awake patient and near-infrared spectroscopy (NIRS). The study aims to determine whether NIRS is equivalent to awake neurological testing in detecting cerebral ischemia during carotid artery clamping and in guiding the use of an intraluminal shunt.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with asymptomatic and symptomatic narrowing of the carotid artery in whom operative treatment is indicated, diagnosed by initial Duplex ultrasonographic examination or CT angiography. * Written consent of the patient to participate in the study Exclusion Criteria: * \- previous hemorrhagic stroke * non-atherosclerotic carotid disease * significant atherosclerotic changes in the aortic arch * hypercoagulable and conditions with embologenic potential (congenital or acquired thrombophilia, malignant disease, atrial fibrillation, significant heart failure and valvular disease)

What they're measuring

primary outcome

Timeframe: two years

Trial details

NCT IDNCT07485933

SponsorClinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

View on ClinicalTrials.gov More Carotid Arteriosclerosis trials