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

Active, not recruiting

• Conditions: Intracranial Aneurysm; Flow Diverter

• 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

Study Timeline

• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-26
• Study Start: 2019-11-04
• Primary Completion: 2023-03-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-09-17
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 234

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)

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

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

Scroll for more (19 remaining)