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

NCT04034810 | Active Not Recruiting

• 1 other identifier: CIP 201802 SILK VISTA
• Study Type: observational
• Target: 234
• Locations: 9 countries
• Sites: 29

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.

Conditions

Intracranial Aneurysm; Flow Diverter

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Safety of silk vista and silk vista baby

  At T0

• Safety of silk vista and silk vista baby

  At hospital discharge

• Safety of silk vista and silk vista baby

  Up to 30 days (-10 / + 21 days) post- procedure.

• Safety of silk vista and silk vista baby

  At 6 months (-2/+3 months) post- procedure.

• Safety of silk vista and silk vista baby

  At 12 months (-3/+6 months) post- procedure.

Interventions

Intracranial aneurysm treated with Silk vista and silk vista baby DEVICE

Patients with intracranial aneurysm(s) intended to be treated with the silk vista and silk vista baby according to standard of care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)
• Patients with recanalized aneurysms previously treated with coils exclusively are also eligible.
• 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)
• Patient ≥ 18 years, who signed an informed consent.

You may not qualify if:

• Patient presenting with contra-indications to the use of silk vista and silk vista babyaccording to the IFU (Instruction for Use).
• Recanalized aneurysms initially treated with stent (including stent assisted coiling)

Sponsors & Collaborators

• Balt Extrusion: lead

Study Sites (29)

Universitätsklinik für Neurologie

Salzburg, A-5020, Austria

Location

CHC Saint Joseph Liège

Liège, 4000, Belgium

Location

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33000, France

Location

Hopital Cavale Blanche

Brest, 29200, France

Location

Hospices Civils de Lyon - Hôpital Neurologique

Bron, 69677, France

Location

CHU Caen, Radiologie interventionelle

Caen, 14033, France

Location

Centre Hospitalier Universitaire Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Centre Hospitalier Universitaire de Grenoble Alpes

Grenoble, 38043, France

Location

Hôpital Kremlin Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Chu Dupuytren Limoges

Limoges, 87000, France

Location

Hôpital Privé Clairval

Marseille, 13009, France

Location

Fondation Rothschild

Paris, 75019, France

Location

Pitié-Salpêtrière Hospital

Paris, 75651, France

Location

CHU Chalre Nicolle

Rouen, 76000, France

Location

Centre Hospitalier Régional Universitaire de Tours

Tours, 37044, France

Location

Munich LMU University

München, 81377, Germany

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

Galilee Medical Center

Nahariya, 22100, Israel

Location

Niguarda Hospital

Milan, 20162, Italy

Location

San Gerardo Hospital

Monza, 20900, Italy

Location

Cà Foncello Hospital

Treviso, 31100, Italy

Location

Santa maria della misericordia hospital

Udine, 33100, Italy

Location

Radboud University medical Center

Nijmegen, 6525 G, Netherlands

Location

Hospital Universitario de cruces

Barakaldo, 48903, Spain

Location

Ramon y Cajal hospital

Madrid, 28034, Spain

Location

Hopsital universidad puerta de hierro

Madrid, 28222, Spain

Location

Unversitario Central de Asturias

Oviedo, 33011, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mario Martinez Galdamez, Dr

  Hospital Clinico Universitario de Valladolid (HCUV), Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 26, 2019
• Study Start: November 4, 2019
• Primary Completion: March 1, 2023
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); IT (4); CR (1); DE (1); AU (1); FR (13); BE (1); IL (2); ES (5)