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

Intracranial Aneurysm Clinical Trial

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.

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04034810
Study type Observational
Source Balt Extrusion
Contact
Status Active, not recruiting
Phase
Start date November 4, 2019
Completion date November 30, 2027
View Details
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