Flow Diverter, Intracranial Aneurysm
Conditions
Brief 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.
Interventions
DEVICEIntracranial 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
Balt Extrusion
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of silk vista and silk vista baby | At T0 | Assessed by the rate of adverse events |
| Efficacy of silk vista and silk vista baby | At T0 | Assessed by aneurysm occlusion rate |
| Technical procedure | At T0 | The practices related to the use of silk vista baby will be describe |
Countries
Austria, Belgium, Croatia, France, Germany, Israel, Italy, Netherlands, Spain
Outcome results
None listed