Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
French Cardiology Society
Conditions:
Carotid Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 surge...
Detailed Description
Carotid atherosclerosis is associated with a high risk of stroke due to embolization from vulnerable plaques located at the carotid bifurcation. When the degree of stenosis exceeds 60%, carotid endart...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT07193225
Start Date
November 1 2025
End Date
November 30 2027
Last Update
September 25 2025
Active Locations (1)
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1
Georges Pompidou European Hospital
Paris, France, 75015