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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Intracranial aneurysm treated with Silk vista and silk vista baby

• Study Type: Observational
• Enrollment (Anticipated): 234

Contacts and Locations

• Study Contact: Name: Saliha HADDAG; Phone Number: +33 1 39 34 90 81; Email: saliha.haddag@baltgroup.com

Study Locations

• Austria
  • Salzburg, Austria, A-5020
    • Universitätsklinik für Neurologie
• Belgium
  • Liège, Belgium, 4000
    • CHC Saint Joseph Liège
• Croatia
  • Zagreb, Croatia, 10000
    • University Hospital Centre Zagreb
• France
  • Bordeaux, France, 33000
    • CHU de Bordeaux - Hôpital Pellegrin
  • Brest, France, 29200
    • Hôpital Cavale Blanche
  • Bron, France, 69677
    • Hospices Civils de Lyon - Hôpital Neurologique
  • Caen, France, 14033
    • CHU Caen, Radiologie interventionelle
  • Clermont Ferrand, France, 63003
    • Centre Hospitalier Universitaire Clermont Ferrand
  • Grenoble, France, 38043
    • Centre Hospitalier Universitaire de Grenoble Alpes
  • Le Kremlin-Bicêtre, France, 94270
    • Hôpital Kremlin Bicetre
  • Limoges, France, 87000
    • CHU Dupuytren Limoges
  • Marseille, France, 13009
    • Hôpital privé Clairval
  • Paris, France, 75651
    • Pitié-Salpêtrière Hospital
  • Paris, France, 75019
    • Fondation Rothschild
  • Rouen, France, 76000
    • CHU Chalre Nicolle
  • Tours, France, 37044
    • Centre Hospitalier Régional Universitaire de Tours
• Germany
  • München, Germany, 81377
    • Munich LMU University
• Israel
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center
  • Nahariya, Israel, 22100
    • Galilee Medical Center
• Italy
  • Milan, Italy, 20162
    • Niguarda Hospital
  • Monza, Italy, 20900
    • San Gerardo Hospital
  • Treviso, Italy, 31100
    • Cà Foncello Hospital
  • Udine, Italy, 33100
    • Santa Maria della Misericordia Hospital
• Netherlands
  • Nijmegen, Netherlands, 6525 G
    • Radboud University Medical Center
• Spain
  • Baracaldo, Spain, 48903
    • Hospital Universitario de Cruces
  • Madrid, Spain, 28034
    • Ramón y Cajal Hospital
  • Madrid, Spain, 28222
    • Hopsital universidad puerta de hierro
  • Oviedo, Spain, 33011
    • Unversitario Central de Asturias
  • Valladolid, Spain, 47003
    • Hospital Clinico universitario de Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with an intracranial aneurysm treated with silk vista and silk vista baby.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	At T0
Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	At hospital discharge
Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	Up to 30 days (-10 / + 21 days) post- procedure.
Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	At 6 months (-2/+3 months) post- procedure.
Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	At 12 months (-3/+6 months) post- procedure.
Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	At 3 years post procedure
Safety of silk vista and silk vista baby	Assessed by the rate of adverse events	At 5 years post procedure
Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	At T0
Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	At hospital discharge
Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	Up to 30 days (-10 / + 21 days) post- procedure.
Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	Up to 6 months (-2/+3 months) post- procedure
Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	Up to 12 months (-3 / + 6 months) post procedure
Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	Up to 3 years post procedure
Efficacy of silk vista and silk vista baby	Assessed by aneurysm occlusion rate	Up to 5 years post procedure
Technical procedure	The practices related to the use of silk vista baby will be describe	At T0

Collaborators and Investigators

• Sponsor: Balt Extrusion

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): November 30, 2027

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CIP 201802 SILK VISTA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No