Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment
- Conditions
- Intracranial Aneurysm
- Registration Number
- NCT04034810
- Lead Sponsor
- Balt Extrusion
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 234
- Patient with intracranial aneurysms intended to be treated with the silk vista and silk vista baby (decision of use silk vista and silk vista baby is done independently and prior to the participation of the patient in the study)
- Patients with recanalized aneurysms previously treated with coils exclusively are also eligible.
- In case of multiple aneurysms, only treatment with silk vista and silk vista baby are allowed (between the initial index procedure to the 12 months follow up visit)
- Patient ≥ 18 years, who signed an informed consent.
- Patient presenting with contra-indications to the use of silk vista and silk vista babyaccording to the IFU (Instruction for Use).
- Recanalized aneurysms initially treated with stent (including stent assisted coiling)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms. At 12-months (-3 / + 6 months) post procedure Characterized by the clinical outcome assessed by mRS of the permanent neurologic deficits and procedure related mortality.
- Secondary Outcome Measures
Name Time Method Efficacy of silk vista and silk vista baby Up to 5 years post procedure Assessed by aneurysm occlusion rate
Safety of silk vista and silk vista baby At 5 years post procedure Assessed by the rate of adverse events
Technical procedure At T0 The practices related to the use of silk vista baby will be describe
Trial Locations
- Locations (29)
Universitätsklinik für Neurologie
🇦🇹Salzburg, Austria
Centre Hospitalier Universitaire de Grenoble Alpes
🇫🇷Grenoble, France
Centre Hospitalier Régional Universitaire de Tours
🇫🇷Tours, France
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Galilee Medical Center
🇮🇱Nahariya, Israel
Niguarda Hospital
🇮🇹Milan, Italy
San Gerardo Hospital
🇮🇹Monza, Italy
Santa maria della misericordia hospital
🇮🇹Udine, Italy
CHC Saint Joseph Liège
🇧🇪Liège, Belgium
Hôpital Privé Clairval
🇫🇷Marseille, France
Ramon y Cajal hospital
🇪🇸Madrid, Spain
CHU Caen, Radiologie interventionelle
🇫🇷Caen, France
Unversitario Central de Asturias
🇪🇸Oviedo, Spain
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
Centre Hospitalier Universitaire Clermont Ferrand
🇫🇷Clermont Ferrand, France
Hopsital universidad puerta de hierro
🇪🇸Madrid, Spain
Chu Dupuytren Limoges
🇫🇷Limoges, France
Cà Foncello Hospital
🇮🇹Treviso, Italy
Radboud University medical Center
🇳🇱Nijmegen, Netherlands
Pitié-Salpêtrière Hospital
🇫🇷Paris, France
Munich LMU University
🇩🇪München, Germany
Hospital Universitario de cruces
🇪🇸Baracaldo, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain
Hôpital Kremlin Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
CHU Chalre Nicolle
🇫🇷Rouen, France
Fondation Rothschild
🇫🇷Paris, France