Comparison of Cerebral Oximetry and Neurological Status Testing in the Awake Patient in the Detec… (NCT07485933) | Clinical Trial Compass
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
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
primary outcome
Timeframe: two years
Trial details
NCT IDNCT07485933
SponsorClinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia