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 | Not Yet Recruiting

• 1 other identifier: 2024-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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 surgery. A non-invasive, non-ionizing 3 dimension mapping of these networks would provide a remarkable benefit for patients.

Conditions

Carotid Atherosclerosis

Outcome Measures

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.

  At day 0

Secondary Outcomes (1)

• Detecting the presence of coronary stenosis

  At day 0

Study Arms (1)

ultrasound localization microscopy

EXPERIMENTAL

The research protocol is integrated into the patient's routine preoperative visit. During this visit, the patient undergoes echocardiography and Doppler ultrasound of the supra-aortic trunks combined with transcranial Doppler. The use of microbubbles (SonoVue®) as a contrast agent is common in cases of poor visualization. We propose to add dedicated ultrasound localization microscopy sequences coupled with SonoVue® injection during this examination in order to image the circle of Willis and the coronary arteries.

Device: Ultrasound localization microscopy, circle of Willis; Device: Ultrasound localization microscopy, coronary arteries

Interventions

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

Ultrasound localization microscopy, coronary arteries DEVICE

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

ultrasound localization microscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• French Cardiology Society: lead

Study Sites (1)

Georges Pompidou European Hospital

Paris, 75015, France

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guillaume GOUDOT, MD

  APHP, Georges Pompidou European Hospital, France

  STUDY CHAIR

• Clément PAPADACCI, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Central Study Contacts

Tessa BERGOT, MSc

CONTACT

+33 1 44 90 70 33; tessa.bergot@sfcardio.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exploratory investigation, first in human, one center, open study,

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 25, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

FR (1)