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Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment
Sponsor: Balt Extrusion
Summary
The FIRST study is an observational, prospective, multi-center, international, single-arm, study. The aim of the study is to collect safety and efficacy information on the use of the silk vista and silk vista baby flow diverter in order to assess clinical safety and performance of the device for treating intracranial aneurysms. All patients with intracranial aneurysm ruptured or unruptured, whatever the localization of the aneurysm, and treated with silk vista or silk vista baby, will be consecutively enrolled in the study. The patient's inclusion and follow up in the study will occur as part of their usual standard of care.
Official title: Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment, an Observational, Prospective, Single Arm, International, Multicenter Study.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
234
Start Date
2019-11-04
Completion Date
2027-11-30
Last Updated
2025-09-17
Healthy Volunteers
No
Conditions
Interventions
Intracranial aneurysm treated with Silk vista and silk vista baby
Patients with intracranial aneurysm(s) intended to be treated with the silk vista and silk vista baby according to standard of care.
Locations (29)
Universitätsklinik für Neurologie
Salzburg, Austria
CHC Saint Joseph Liège
Liège, Belgium
University Hospital Centre Zagreb
Zagreb, Croatia
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
Hopital Cavale Blanche
Brest, France
Hospices Civils de Lyon - Hôpital Neurologique
Bron, France
CHU Caen, Radiologie interventionelle
Caen, France
Centre Hospitalier Universitaire Clermont Ferrand
Clermont-Ferrand, France
Centre Hospitalier Universitaire de Grenoble Alpes
Grenoble, France
Hôpital Kremlin Bicêtre
Le Kremlin-Bicêtre, France
Chu Dupuytren Limoges
Limoges, France
Hôpital Privé Clairval
Marseille, France
Fondation Rothschild
Paris, France
Pitié-Salpêtrière Hospital
Paris, France
CHU Chalre Nicolle
Rouen, France
Centre Hospitalier Régional Universitaire de Tours
Tours, France
Munich LMU University
München, Germany
Hadassah Medical Center
Jerusalem, Israel
Galilee Medical Center
Nahariya, Israel
Niguarda Hospital
Milan, Italy
San Gerardo Hospital
Monza, Italy
Cà Foncello Hospital
Treviso, Italy
Santa maria della misericordia hospital
Udine, Italy
Radboud University medical Center
Nijmegen, Netherlands
Hospital Universitario de cruces
Barakaldo, Spain
Ramon y Cajal hospital
Madrid, Spain
Hopsital universidad puerta de hierro
Madrid, Spain
Unversitario Central de Asturias
Oviedo, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Spain