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

B

Balt

Status

Active, not recruiting

Conditions

Intracranial Aneurysm

Treatments

Device: Intracranial aneurysm treated with Silk vista and silk vista baby

Study type

Observational

Funder types

Industry

Identifiers

NCT04034810
CIP 201802 SILK VISTA

Details and patient eligibility

About

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.

Enrollment

234 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

29

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Data sourced from clinicaltrials.gov

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