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

Intracranial Aneurysm Clinical Trial

— FIRST  

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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04034810
• Other study ID #: CIP 201802 SILK VISTA
• Status: Active, not recruiting
• Start date: November 4, 2019
• Est. completion date: November 30, 2027

Study information

• Verified date: March 2022
• Source: Balt Extrusion
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 234
• Est. completion date: November 30, 2027
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

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.

Locations

Country	Name	City	State
Austria	Universitätsklinik für Neurologie	Salzburg
Belgium	CHC Saint Joseph Liège	Liège
Croatia	University Hospital Centre Zagreb	Zagreb
France	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
Germany	Munich LMU University	München
Israel	Hadassah Medical Center	Jerusalem
Israel	Galilee Medical Center	Nahariya
Italy	Niguarda Hospital	Milan
Italy	San Gerardo Hospital	Monza
Italy	Cà Foncello Hospital	Treviso
Italy	Santa maria della misericordia hospital	Udine
Netherlands	Radboud University medical Center	Nijmegen
Spain	Hospital Universitario de cruces	Baracaldo
Spain	Hopsital universidad puerta de hierro	Madrid
Spain	Ramon y Cajal hospital	Madrid
Spain	Unversitario Central de Asturias	Oviedo
Spain	Hospital Clinico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Balt Extrusion

Countries where clinical trial is conducted

Austria,  Belgium,  Croatia,  France,  Germany,  Israel,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms.	Characterized by the rate of the permanent neurologic deficits and procedure related mortality.	At 12-months (-3 / + 6 months) post procedure
Primary	Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms.	Characterized by the clinical outcome assessed by mRS of the permanent neurologic deficits and procedure related mortality.	At 12-months (-3 / + 6 months) post procedure
Secondary	Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	At T0
Secondary	Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	At hospital discharge
Secondary	Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	Up to 30 days (-10 / + 21 days) post- procedure.
Secondary	Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	At 6 months (-2/+3 months) post- procedure.
Secondary	Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	At 12 months (-3/+6 months) post- procedure.
Secondary	Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	At 3 years post procedure
Secondary	Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	At 5 years post procedure
Secondary	Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	At T0
Secondary	Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	At hospital discharge
Secondary	Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	Up to 30 days (-10 / + 21 days) post- procedure.
Secondary	Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	Up to 6 months (-2/+3 months) post- procedure
Secondary	Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	Up to 12 months (-3 / + 6 months) post procedure
Secondary	Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	Up to 3 years post procedure
Secondary	Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	Up to 5 years post procedure
Secondary	Technical procedure	The practices related to the use of silk vista baby will be describe	At T0