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

NCT ID: NCT07193225

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-11-30

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.

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.

Conditions

Carotid Atherosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ultrasound localization microscopy, circle of Willis

Intervention Type: DEVICE

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

Ultrasound localization microscopy, coronary arteries

Intervention Type: DEVICE

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

Interventions

Ultrasound localization microscopy, circle of Willis

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

Intervention Type: DEVICE

Ultrasound localization microscopy, coronary arteries

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French Cardiology Society

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume GOUDOT, MD

Role: STUDY_CHAIR

APHP, Georges Pompidou European Hospital, France

Clément PAPADACCI, PhD

Role: STUDY_DIRECTOR

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

Locations

Georges Pompidou European Hospital

Paris, , France

Countries

France

Central Contacts

Tessa BERGOT, MSc

Role: CONTACT

tessa.bergot@sfcardio.fr

+33 1 44 90 70 33

Facility Contacts

Guillaume GOUDOT, MD

Role: primary

guillaume.goudot@aphp.fr

+33 1 56 09 30 51

Other Identifiers

2024-01

Identifier Type: -

Identifier Source: org_study_id