Carotid AtherosclerosisMicroflow3DNCT07193225
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
A study testing Ultrasound localization microscopy, circle of Willis and Ultrasound localization microscopy, coronary arteries in people with Carotid Atherosclerosis, run by French Cardiology Society at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Atherosclerosis
- What is being tested?
- Ultrasound localization microscopy, circle of Willis and Ultrasound localization microscopy, coronary arteries
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2025to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Georges Pompidou European Hospital
Paris, 75015
Guillaume GOUDOT, MD, +33 1 56 09 30 51, guillaume.goudot@aphp.fr
About this study
Official title: 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.
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.
- Conditions
- Carotid Atherosclerosis
- Being tested
- Ultrasound localization microscopy, circle of Willis, Ultrasound localization microscopy, coronary arteries
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound localization microscopy, circle of WillisDevice
Ultrasound localization microscopy sequences coupled with SonoVue® injection of the circle of Willis before carotid endarterectomy
Ultrasound localization microscopy, coronary arteriesDevice
ultrasound localization microscopy sequences coupled with SonoVue® injection of coronary arteries before carotid endarterectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultrasound localization microscopy, circle of Willis; Device: Ultrasound localization microscopy, coronary arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory investigation, first in human, one center, open study,
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume GOUDOT, MD, Study chair, APHP, Georges Pompidou European Hospital, FranceClément PAPADACCI, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193225
- Sponsor's protocol ID
- 2024-01
- Acronym
- Microflow3D
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07193225
- Acronym / sponsor ID
- Microflow3D / 2024-01
- Conditions
- Carotid Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory investigation, first in human, one center, open study,
| Arm | Type | Receives |
|---|---|---|
| ultrasound localization microscopy | Experimental | Device: Ultrasound localization microscopy, circle of Willis, Device: Ultrasound localization microscopy, coronary arteriesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound localization microscopy, circle of WillisUltrasound localization microscopy sequences coupled with SonoVue® injection of the circle of Willis before carotid endarterectomy | Device | ultrasound localization microscopy |
| Ultrasound localization microscopy, coronary arteriesultrasound localization microscopy sequences coupled with SonoVue® injection of coronary arteries before carotid endarterectomy | Device | ultrasound localization microscopy |
Primary outcome
Detecting the presence of an incomplete circle of Willis
Time frame: At day 0
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.
1 secondary outcome
Detecting the presence of coronary stenosis
Time frame: At day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound localization microscopy, circle of Willis and Ultrasound localization microscopy, coronary arteries in people with Carotid Atherosclerosis, run by French Cardiology Society at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tessa BERGOT, MSc (+33 1 44 90 70 33, tessa.bergot@sfcardio.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detecting the presence of an incomplete circle of Willis (time frame: At day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.