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 (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 - Microflow3D

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carotid Atherosclerosis
• Intervention / Treatment: Device: Ultrasound localization microscopy, circle of Willis; Device: Ultrasound localization microscopy, coronary arteries

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 endarterectomy is considered to remove the plaque. This is a complex surgical procedure, performed under general anesthesia in most cases, and consists of extracting the plaque. The patient population is typically elderly and particularly fragile, with a significant risk of cerebral infarction during the intervention. To minimize perioperative risks, patients undergo a preoperative evaluation that includes transcranial Doppler ultrasound and coronary angiography. The purpose of transcranial Doppler is to image the circle of Willis and identify patients with an incomplete circle, which would compromise adequate cerebral perfusion during carotid clamping. However, this imaging is challenging because the quality of ultrasound through the skull is often poor, and two-dimensional imaging does not always allow full visualization of the circle of Willis. A high-resolution three-dimensional imaging modality could therefore improve surgical planning. Coronary angiography or CT coronary angiography are performed to image the coronary arteries and identify patients at highest risk of myocardial infarction. A non-ionizing three-dimensional imaging modality with high coronary resolution could also benefit patients by reducing radiation exposure.

Ten years ago, the Physics for Medicine Laboratory developed a novel imaging technique called ultrasound localization microscopy (ULM). This modality combines ultrafast ultrasound imaging (acquiring more than 1000 frames per second) with the injection of microbubbles already used in clinical practice. By individually imaging and localizing these microbubbles, it becomes possible to visualize the vascular networks of the coronary arteries and the brain in animal models with unprecedented resolution and field of view. Recently, the clinical feasibility of ultrasound localization microscopy was demonstrated in two dimensions in the brain of patients with cerebral aneurysms.

Nevertheless, the two-dimensional nature of the imaging represented a limitation. To address this, we developed a new type of wider ultrasound probe capable of imaging large three-dimensional volumes. These probes have already been validated through simulations, phantom studies, and more recently in animal experiments.

In this clinical study, we therefore aim to demonstrate the feasibility of three-dimensional imaging of the microcirculation of the heart and brain in patients during the preoperative evaluation, with the goal of improving surgical planning for carotid endarterectomy.

• Study Type: Interventional
• Enrollment (Estimated): 37
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tessa BERGOT, MSc; Phone Number: +33 1 44 90 70 33; Email: tessa.bergot@sfcardio.fr

Study Locations

• France
  • Paris, France, 75015
    • Georges Pompidou European hospital
    • Contact: Guillaume GOUDOT, MD; Phone Number: +33 1 56 09 30 51; Email: guillaume.goudot@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ultrasound localization microscopy; 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; Ultrasound localization microscopy sequences coupled with SonoVue® injection of the circle of Willis before carotid endarterectomy; Device: Ultrasound localization microscopy, coronary arteries; ultrasound localization microscopy sequences coupled with SonoVue® injection of coronary arteries before carotid endarterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At day 0

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Investigators: Study Chair: Guillaume GOUDOT, MD, APHP, Georges Pompidou European Hospital, France; Study Director: Clément PAPADACCI, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: September 18, 2025
• First Submitted That Met QC Criteria: September 18, 2025
• First Posted (Estimated): September 25, 2025

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases
• Other Study ID Numbers: 2024-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No