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Clinical Trials in the Netherlands / NCT04034810
Active, not recruiting Observational

Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment

NCT04034810 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Balt Extrusion
Phase
Observational
Started
2019-11-04
Last updated
2025-09-17

Condition(s) studied

Intracranial AneurysmFlow Diverter

Investigational drug(s) / intervention(s)

Intracranial aneurysm treated with Silk vista and silk vista baby

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 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) 2. Patients with recanalized aneurysms previously treated with coils exclusively are also eligible. 3. 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) 4. Patient ≥ 18 years, who signed an informed consent. Exclusion Criteria: 1. Patient presenting with contra-indications to the use of silk vista and silk vista babyaccording to the IFU (Instruction for Use). 2. Recanalized aneurysms initially treated with stent (including stent assisted coiling)

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
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

Other trials for the same condition

@neurIST : Intregrated Biomedical Informatics for the Management of Cerebral Aneurysms Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04034810 on ClinicalTrials.gov ↗ ← All trials in the Netherlands