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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrench Cardiology Society

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Ultrasound localization microscopy, circle of Willis

    Device

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

  • Ultrasound localization microscopy, coronary arteries

    Device

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

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: ultrasound localization microscopyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At day 0

Secondary outcomes

1

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.

Time frame
At day 0

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: