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.
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
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
Single group
3D CEUS
DeviceSYLVER 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.
Qualitative agreement between SYLVER 3D CEUS and 3D Rotational Angiography for aneurysmal sac hemodynamic analysis
Agreement between SYLVER 3D contrast-enhanced ultrasound and 3D rotational angiography (3DRA, reference technique) for qualitative parameters: aneurysm presence, location and shape; intrasaccular flow organization (jet, recirculation, stagnation); complete or partial sac filling. Agreement is expressed as observed percent agreement and, where relevant, kappa coefficient. Analysis is descriptive; no success threshold or statistical hypothesis is pre-specified.
Quantitative agreement between SYLVER 3D CEUS and 3D Rotational Angiography for aneurysmal sac hemodynamic parameters
Association and agreement between SYLVER 3D CEUS and 3DRA for quantitative hemodynamic parameters of the aneurysmal sac derived from the time-intensity curve (time of arrival, time to peak) and flow velocity (notably pulsatility index), analyzed in relation to intrasaccular flow organization. Association is assessed by Spearman correlation coefficient with 95% CI, and agreement by Bland-Altman limits of agreement. Analysis is descriptive.
Feasibility of the multimodal angiography and 3D Ultrasound approach
Number and percentage (with 95% CI) of participants with usable angiographic and ultrasound acquisitions, feasible co-registration of both modalities, and interpretable hemodynamic analysis of the aneurysmal sac.
Healthcare staff time with SYLVER
Time (minutes) spent by physicians, nursing assistants, radiographers and radiologists, measured with SYLVER.
Associated costs with SYLVER
Costs (euros) associated with the measured staff time, with SYLVER, to estimate the medico-economic impact of SYLVER use.
Incidence of Adverse Events, Serious Adverse Events and Device Deficiencies
Number and percentage of participants with adverse events (AEs) and serious adverse events (SAEs), and number of SYLVER device deficiencies, recorded in the eCRF.
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Resolve Stroke
Lead sponsor
Nantes University Hospital
Collaborator
