Name: Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment, an Observational, Prospective, Single Arm, International, Multicenter Study.
Creator: Trial Radar
Published: 2025-09-17
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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

Active, not recruiting

Clinical Trial NCT04034810 (FIRST) is an observational study for Intracranial Aneurysm, Flow Diverter that is active, not recruiting. It started on 4 November 2019 with plans to enroll 234 participants. Led by Balt Extrusion, it is expected to complete by 30 November 2027. The latest data from ClinicalTrials.gov was last updated on 17 September 2025.

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.

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.

Conditions

Intracranial AneurysmFlow Diverter

Other Study IDs

FIRST
CIP 201802 SILK VISTA

NCT ID Number

NCT04034810

Start Date (Actual)

2019-11-04

Last Update Posted

2025-09-17

Completion Date (Estimated)

2027-11-30

Enrollment (Estimated)

234

Study Type

Observational

Status

Active, not recruiting

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
N/A	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.

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

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

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.

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)

Balt Extrusion

No contact data.

29 Study Locations in 9 Countries

Austria

Universitätsklinik für Neurologie, Salzburg, A-5020, Austria

Belgium

CHC Saint Joseph Liège, Liège, 4000, Belgium

Croatia

University Hospital Centre Zagreb, Zagreb, 10000, Croatia

France

CHU de Bordeaux - Hôpital Pellegrin, Bordeaux, 33000, France

Hopital Cavale Blanche, Brest, 29200, France

Hospices Civils de Lyon - Hôpital Neurologique, Bron, 69677, France

CHU Caen, Radiologie interventionelle, Caen, 14033, France

Centre Hospitalier Universitaire Clermont Ferrand, Clermont-Ferrand, 63003, France

Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, 38043, France

Hôpital Kremlin Bicêtre, Le Kremlin-Bicêtre, 94270, France

Chu Dupuytren Limoges, Limoges, 87000, France

Hôpital Privé Clairval, Marseille, 13009, France

Fondation Rothschild, Paris, 75019, France

Pitié-Salpêtrière Hospital, Paris, 75651, France

CHU Chalre Nicolle, Rouen, 76000, France

Centre Hospitalier Régional Universitaire de Tours, Tours, 37044, France

Germany

Munich LMU University, München, 81377, Germany

Israel

Hadassah Medical Center, Jerusalem, 9112001, Israel

Galilee Medical Center, Nahariya, 22100, Israel

Italy

Niguarda Hospital, Milan, 20162, Italy

San Gerardo Hospital, Monza, 20900, Italy

Cà Foncello Hospital, Treviso, 31100, Italy

Santa maria della misericordia hospital, Udine, 33100, Italy

Netherlands

Radboud University medical Center, Nijmegen, 6525 G, Netherlands

Spain

Hospital Universitario de cruces, Barakaldo, 48903, Spain

Ramon y Cajal hospital, Madrid, 28034, Spain

Hopsital universidad puerta de hierro, Madrid, 28222, Spain

Unversitario Central de Asturias, Oviedo, 33011, Spain

Hospital Clinico Universitario de Valladolid, Valladolid, 47003, Spain

Clinical Trial Radar

Type

Study Type

Age Group

Biological Sex

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

Placebo

Type

Study Type

Age Group

Biological Sex

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

Inclusion Criteria

Exclusion Criteria