[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659345":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":37,"interventions":44,"overallOfficials":30,"centralContacts":50,"locations":56,"responsibleParty":75,"collaborators":77,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":30,"enrollmentInfo":90,"targetDuration":30,"studyType":93,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":59,"whyStopped":30,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Resolve Stroke","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","Day 1",{"measure":14,"description":15,"timeFrame":12},"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.",[17,20,23,26],{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"Healthcare staff time with SYLVER","Time (minutes) spent by physicians, nursing assistants, radiographers and radiologists, measured with SYLVER.",{"measure":24,"description":25,"timeFrame":12},"Associated costs with SYLVER","Costs (euros) associated with the measured staff time, with SYLVER, to estimate the medico-economic impact of SYLVER use.",{"measure":27,"description":28,"timeFrame":29},"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.","From inclusion to end of participation (Day 1)",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"SYLVER 3D CEUS and 3D Rotational Angiography","EXPERIMENTAL","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.",[43],"Device: 3D CEUS",[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":30},"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.",[39],[51],{"name":52,"role":53,"phone":54,"phoneExt":30,"email":55},"Jonathan Lavaud, PhD","CONTACT","+33750529940","jonathan.lavaud@resolvestroke.com",[57],{"facility":58,"status":59,"city":60,"state":30,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Nantes University Hospital","RECRUITING","Nantes","44000","France","FR",{"type":65,"coordinates":66},"Point",[67,68],-1.55336,47.21725,{"lat":68,"lon":67},[71],{"name":72,"role":53,"phone":73,"phoneExt":30,"email":74},"Romain Bourcier, M.D.; Ph.D.","+33(0)2 40 16 56 31","romain.bourcier@chu-nantes.fr",{"type":76,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[78],{"name":58,"class":79},"OTHER","100659345","multimodal-approach-feasability-study-for-untreated-and-unruptured-intracranial-aneurysms-100659345",false,"NCT07864389","Multimodal Approach Feasability Study for Untreated and Unruptured Intracranial Aneurysms","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","miniCAN","Inclusion Criteria:\n\n* Adult patients (≥ 18 years of age)\n* Informed consent signed by the patient\n* Enrolled in a social security program or covered by an equivalent program\n* 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\n* Indications for diagnostic cerebral arteriography within a 6-month period following the discovery of one or more unruptured aneurysms\n\nExclusion Criteria:\n\n* Unusable temporal window\n* Withdrawal of Consent by the Patient\n* Cancellation of the appointment for a cerebral angiography\n* At the investigator's initiative, in the patient's best interest","ALL","18 Years",{"count":91,"type":92},15,"ESTIMATED","INTERVENTIONAL",[32],"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.",[97],"Aneurysm Cerebral (Unruptured)",[99,100,101,102],"3DRA","Ultrasound","CEUS","aneurysm","2026-10-07",{"date":105,"type":106},"2026-10-13","ACTUAL",{"date":108,"type":92},"2026-10-05",{"date":110,"type":92},"2026-12",{"name":5,"class":6},1]