About this trial
There is a need to simplify the assessment of coronary and cerebral vascular networks in patients selected for carotid endarterectomy in order to prevent potential complications during and after surgery. A non-invasive, non-ionizing 3 dimension mapping of these networks would provide a remarkable benefit for patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with asymptomatic carotid stenosis, without recent stroke, and scheduled for carotid endarterectomy within the next 30 days.
Age ≥ 18 years.
Beneficiary of a social security system or equivalent coverage.
Signed informed consent.
Disqualifiers
Contraindication to the use of the ultrasound contrast agent SonoVue®: known hypersensitivity to the active substance or to any of the following excipients: Macrogol 4000; Distearoylphosphatidylcholine; Sodium dipalmitoylphosphatidylglycerol; Palmitic acid.
Allergy to ultrasound gel.
Refusal or inability (linguistic or psychological) to sign the informed consent form.
Subject to legal protection measures, such as guardianship (in accordance with Article L1122-2 of the French Public Health Code).
Trial design
Single group
Treatments tested in this trial
Ultrasound localization microscopy, circle of Willis
DeviceUltrasound localization microscopy sequences coupled with SonoVue® injection of the circle of Willis before carotid endarterectomy
Ultrasound localization microscopy, coronary arteries
Deviceultrasound localization microscopy sequences coupled with SonoVue® injection of coronary arteries before carotid endarterectomy
Treatment groups
Trial outcomes
Primary outcomes
Detecting the presence of an incomplete circle of Willis
Detection of all arteries of the circle of Willis using ultrasound localization microscopy, compared with cerebral Computed Tomography angiography or Magnetic Resonance Imaging, routinely performed before carotid endarterectomy.
Secondary outcomes
Detecting the presence of coronary stenosis
Detection of coronary stenosis using ultrasound localization microscopy, compared with coronary Computed Tomography angiography or coronary angiography, routinely performed before carotid endarterectomy.
Sponsors and contacts
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