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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms. — At 12-months (-3 / + 6 months) post procedure
  Characterized by the rate of the permanent neurologic deficits and procedure related mortality.
• Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms. — 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.

Trial sites (29)

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