NCT04034810

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

Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment, an Observational, Prospective, Single Arm, International, Multicenter Study.

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 234 (estimated)
• Sponsor: Balt Extrusion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Aneurysm
• Flow Diverter

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2019-11-04
• Primary completion: 2023-03-01
• Completion: 2027-11-30
• First posted: 2019-07-26
• Last updated: 2025-09-17

Locations

29 sites across 9 countries: Austria, Belgium, Croatia, France, Germany, Israel, Italy, Netherlands, Spain