Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment
Lead Sponsor:
Balt Extrusion
Conditions:
Intracranial Aneurysm
Flow Diverter
Eligibility:
All Genders
18+ years
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 si...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
November 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT04034810
Start Date
November 4 2019
End Date
November 30 2027
Last Update
September 17 2025
Active Locations (29)
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1
Universitätsklinik für Neurologie
Salzburg, Austria, A-5020
2
CHC Saint Joseph Liège
Liège, Belgium, 4000
3
University Hospital Centre Zagreb
Zagreb, Croatia, 10000
4
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France, 33000