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

NCT04034810 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 234

Last updated 2025-09-17

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Balt Extrusion

    lead INDUSTRY

Principal Investigators

  • Mario Martinez Galdamez, Dr · Hospital Clinico Universitario de Valladolid (HCUV), Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2023-03-01
Completion
2027-11-30

Countries

  • Austria
  • Belgium
  • Croatia
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04034810 on ClinicalTrials.gov