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Clinical Trials in France / NCT07193225
Starting soon Not applicable

Microflow3D - Non-invasive Mapping of Coronary Arteries and the Cerebral Vascular Network Using 3D Ultrasound Localization Microscopy in Patients With Atherosclerosis Prior to Carotid Endarterectomy Surgery

NCT07193225 · tracked via the Priya Life Science France tracker
Sponsor
French Cardiology Society
Phase
Not applicable
Started
2025-11-01
Last updated
2025-09-25

Condition(s) studied

Carotid Atherosclerosis

Investigational drug(s) / intervention(s)

Ultrasound localization microscopy, circle of WillisUltrasound localization microscopy, coronary arteries

Ultrasound localization microscopy, circle of Willis: Ultrasound localization microscopy sequences coupled with SonoVue® injection of the circle of Willis before carotid endarterectomy

Ultrasound localization microscopy, coronary arteries: ultrasound localization microscopy sequences coupled with SonoVue® injection of coronary arteries before carotid endarterectomy

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. * Patients already enrolled in another biomedical research study may also participate in this study. Exclusion Criteria: * 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). * Pregnant or breastfeeding women cannot participate in this study.

Primary outcome measure(s)

  • Detecting the presence of an incomplete circle of Willis — At day 0
    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.

Trial sites (1)

FacilityCityRegionStatus
Georges Pompidou European Hospital Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07193225 on ClinicalTrials.gov ↗ ← All trials in France