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Ultrasound imaging of brain aneurysms that have not burst and are untreated

Tests a 3D ultrasound system for viewing unruptured brain aneurysms in adults.

Key facts

Who runs it
Resolve Stroke
Where
Nantes, FranceSee the site
Trial code
Registry title
Multimodal Approach Feasability Study for Untreated and Unruptured Intracranial Aneurysms
Status
Recruiting
People taking part
15 people, planned
Started
5 Oct 2026
Expected to end
Dec 2026
Type of study
Interventional
Treatments tested
  • 3D CEUS
Record updated
13 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with one or more brain aneurysms (bulges in a brain artery) that have not burst and have not been treated. They must already be planned for a brain artery X-ray exam (angiography).

Age
18 years and older
Sex
All sexes
Disease stage
One or more unruptured, untreated intracranial aneurysms, usually found by chance, of 3 mm or more. They must sit at the base of the circle of Willis: the Sylvian bifurcation, the anterior or posterior communicating artery, or the end of the carotid or basilar artery.
Earlier treatment
The aneurysm must not have been treated. A diagnostic cerebral angiography must be planned within 6 months after the aneurysm was found.

Main reasons for not taking part

  • The ultrasound cannot pass through the skull at the temple
  • The person withdraws consent
  • The cerebral angiography appointment is cancelled
  • The investigator decides it is in the person's interest not to take part
  • No social security or similar health coverage

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • Adult patients (≥ 18 years of age)
  • Informed consent signed by the patient
  • Enrolled in a social security program or covered by an equivalent program
  • Presence of one or more unruptured, untreated intracranial aneurysms; typically bifurcation aneurysms, incidentally discovered, with a size of ≥ 3 mm; located at the base of the polygon of Willis in the Sylvian bifurcation, the anterior or posterior communicating artery, or the carotid or basilar terminal segments
  • Indications for diagnostic cerebral arteriography within a 6-month period following the discovery of one or more unruptured aneurysms

Who cannot take part

  • Unusable temporal window
  • Withdrawal of Consent by the Patient
  • Cancellation of the appointment for a cerebral angiography
  • At the investigator's initiative, in the patient's best interest

Where in France

  • Nantes University HospitalNantes, FranceContact: Romain Bourcier, M.D.; Ph.D.Taking people

About the trial

What the trial wants to find out

This feasibility study aims to evaluate the SYLVER system's ability to visualize intracranial aneurysms in accordance with 3D rotational angiography (3DRA) as the reference technique.

The group in the trial

  • SYLVER 3D CEUS and 3D Rotational AngiographyTreatment being tested

    Participants undergo their standard-of-care diagnostic cerebral angiography, including 3D rotational angiography (3DRA), during a day hospitalization. During the same visit, a single research acquisition of 3D contrast-enhanced transcranial ultrasound is performed with the SYLVER imaging system (investigational, non-invasive, class IIa, not CE-marked) through the temporal acoustic window, after intravenous injection of an ultrasound contrast agent (SonoVue®). The research procedure lasts up to 30 minutes. Qualitative and quantitative hemodynamic parameters of the aneurysmal sac obtained with SYLVER are compared with 3DRA as the reference technique. Follow-up is limited to the day of the procedure.

    Treatment: 3D CEUS

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Proof of Concept Study to Evaluate the Feasibility of a Multimodal Approach Combining Angiography and 3D Ultrasound for the Hemodynamic Analysis of Unruptured, Untreated Intracranial Aneurysms
Plain-language title
Ultrasound imaging of brain aneurysms that have not burst and are untreatedGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
13 October 2026