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RECRUITING
NCT07864389
NA

Multimodal Approach Feasability Study for Untreated and Unruptured Intracranial Aneurysms

Sponsor: Resolve Stroke

View on ClinicalTrials.gov

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

Interventions

DEVICE

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