Active, not recruitingNo phase
Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment
Key facts
- Who runs it
- Balt Extrusion
- Where
- Austria, Belgium, Croatia, France, Germany, Israel, Italy, Netherlands, and Spain29 sites in 9 countriesChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 234 people, planned
- Started
- 4 Nov 2019
- Expected to end
- 30 Nov 2027
- Type of study
- Observational
- Treatments tested
- Intracranial aneurysm treated with Silk vista and silk vista baby
- Record updated
- 29 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- Recanalized aneurysms initially treated with stent (including stent assisted coiling)
- Patient presenting with contra-indications to the use of silk vista and silk vista babyaccording to the IFU (Instruction for Use)
This trial has no sites in United States.
It has sites in 9 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
Treatments tested
- Intracranial aneurysm treated with Silk vista and silk vista baby
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official 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.
- Record updated
- 29 September 2026