Feasibility test of the SYLVER system to image unruptured intracranial aneurysms using 3D ultrasound compared with 3D rotational angiography

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the SYLVER system, using 3D contrast-enhanced ultrasound to image unruptured intracranial aneurysms. It compares visualization achieved with SYLVER to the reference standard of 3D rotational angiography. Eligible participants are adults with one or more unruptured, untreated aneurysms identified incidentally and requiring diagnostic cerebral angiography within six months. The trial is conducted as an interventional feasibility assessment at Nantes University Hospital with Resolve Stroke as lead sponsor. Enrollment and procedures follow indicated consent and standard safety oversight.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 it's running

• Nantes University Hospital
  Nantes, France Recruiting

Study contacts

• Study coordinator: Jonathan Lavaud, PhD
• Email: jonathan.lavaud@resolvestroke.com
• Phone: +33750529940

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.