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Multimodal Approach Feasability Study for Untreated and Unruptured Intracranial Aneurysms
Sponsor: Resolve Stroke
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-10-05
Completion Date
2026-12
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
3D CEUS
SYLVER is the investigational, non-invasive, class IIa ultrasound imaging system providing three-dimensional contrast-enhanced ultrasound (3D CEUS) imaging of the cerebral vasculature through the skull. Transcranial 3D CEUS acquisition is performed via the temporal acoustic window during the day-hospitalization for standard-of-care follow-up cerebral angiography, for a maximum of 30 minutes. Acquisitions are used to assess aneurysm presence, location and shape, intrasaccular flow organization (jet, recirculation, stagnation), filling completeness, and time-intensity curve and flow velocity parameters (time of arrival, time to peak, pulsatility index), which are compared with 3D rotational angiography.
Locations (1)
Nantes University Hospital
Nantes, France