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NCT Number: NCT04034810

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik für Neurologie, Salzburg, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms.

    Time frame: At 12-months (-3 / + 6 months) post procedure

    Characterized by the rate of the permanent neurologic deficits and procedure related mortality.

  2. Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms.

    Time frame: At 12-months (-3 / + 6 months) post procedure

    Characterized by the clinical outcome assessed by mRS of the permanent neurologic deficits and procedure related mortality.

Secondary outcomes

  1. Safety of silk vista and silk vista baby

    Time frame: At T0

    Assessed by the rate of adverse events

  2. Safety of silk vista and silk vista baby

    Time frame: At hospital discharge

    Assessed by the rate of adverse events

  3. Safety of silk vista and silk vista baby

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

    Assessed by the rate of adverse events

  4. Safety of silk vista and silk vista baby

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

    Assessed by the rate of adverse events

  5. Safety of silk vista and silk vista baby

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

    Assessed by the rate of adverse events

  6. Safety of silk vista and silk vista baby

    Time frame: At 3 years post procedure

    Assessed by the rate of adverse events

  7. Safety of silk vista and silk vista baby

    Time frame: At 5 years post procedure

    Assessed by the rate of adverse events

  8. Efficacy of silk vista and silk vista baby

    Time frame: At T0

    Assessed by aneurysm occlusion rate

  9. Efficacy of silk vista and silk vista baby

    Time frame: At hospital discharge

    Assessed by aneurysm occlusion rate

  10. Efficacy of silk vista and silk vista baby

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

    Assessed by aneurysm occlusion rate

  11. Efficacy of silk vista and silk vista baby

    Time frame: Up to 6 months (-2/+3 months) post- procedure

    Assessed by aneurysm occlusion rate

  12. Efficacy of silk vista and silk vista baby

    Time frame: Up to 12 months (-3 / + 6 months) post procedure

    Assessed by aneurysm occlusion rate

  13. Efficacy of silk vista and silk vista baby

    Time frame: Up to 3 years post procedure

    Assessed by aneurysm occlusion rate

  14. Efficacy of silk vista and silk vista baby

    Time frame: Up to 5 years post procedure

    Assessed by aneurysm occlusion rate

  15. Technical procedure

    Time frame: At T0

    The practices related to the use of silk vista baby will be describe

Sponsors and collaborators

Lead sponsor

Balt Extrusion

Industry

Registry information

Official study 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.

Acronym: FIRST

Important dates

Study start
2019
Primary completion
2023
Study completion
2027
First posted
Jul 26, 2019
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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