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

About the 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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

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.

EXCLUSION CRITERIA

Exclusion Criteria:

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)

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details

Contition

Intracranial Aneurysm,Flow Diverter

Age (in years)

18+

Participants needed

234

Est. Completion Date

Nov 30, 2027

Treatment type

OBSERVATIONAL

Sponsor

Balt Extrusion

ClinicalTrials.gov identifier

NCT04034810

Study number

CIP 201802 SILK VISTA

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