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Not yet recruitingNCT07193225Microflow3DUpdated Sep 25, 2025

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

An interventional study of Ultrasound localization microscopy, circle of Willis and Ultrasound localization microscopy, coronary arteries in Carotid Atherosclerosis, sponsored by French Cardiology Society. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by French Cardiology Society · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Carotid Atherosclerosis
03

In context

Carotid Artery Diseases

248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.

This study's planned enrollment of 37 is below the median of 120 across 118 interventional studies indexed under Carotid Artery Diseases.

Browse Carotid Artery Diseases studies →

Lead sponsor

French Cardiology Society is the lead sponsor of 84 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (estimated)

Study arms

  • 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 · Device: Ultrasound localization microscopy, coronary arteries

Interventions

  • DeviceUltrasound localization microscopy, circle of Willis

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

  • DeviceUltrasound localization microscopy, coronary arteries

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

06

What researchers measure

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

07

Study locations

1 site
  • Georges Pompidou European Hospital
    Paris, 75015, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07193225
Lead sponsor
French Cardiology Society
Responsible party
Sponsor
First posted
Sep 25, 2025
Start date
Nov 1, 2025 (estimated)
Primary completion
Nov 30, 2027 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Sep 25, 2025

Study contacts

Tessa BERGOT, MSc
Contact
tessa.bergot@sfcardio.fr
+33 1 44 90 70 33
Guillaume GOUDOT, MD
study chair · APHP, Georges Pompidou European Hospital, France
Clément PAPADACCI, PhD
study director · Institut National de la Santé Et de la Recherche Médicale, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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