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

Study Overview
=================
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.

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.

Conditions
-----------------
Intracranial Aneurysm

Intervention / Treatment
-----------------
* Device: Intracranial aneurysm treated with Silk vista and silk vista baby


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms. | Characterized by the rate of the permanent neurologic deficits and procedure related mortality. | At 12-months (-3 / + 6 months) post procedure | 
| Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms. | Characterized by the clinical outcome assessed by mRS of the permanent neurologic deficits and procedure related mortality. | At 12-months (-3 / + 6 months) post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | At T0 | 
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | At hospital discharge | 
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | Up to 30 days (-10 / + 21 days) post- procedure. | 
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | At 6 months (-2/+3 months) post- procedure. | 
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | At 12 months (-3/+6 months) post- procedure. | 
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | At 3 years post procedure | 
| Safety of silk vista and silk vista baby | Assessed by the rate of adverse events | At 5 years post procedure | 
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | At T0 | 
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | At hospital discharge | 
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | Up to 30 days (-10 / + 21 days) post- procedure. | 
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | Up to 6 months (-2/+3 months) post- procedure | 
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | Up to 12 months (-3 / + 6 months) post procedure | 
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | Up to 3 years post procedure | 
| Efficacy of silk vista and silk vista baby | Assessed by aneurysm occlusion rate | Up to 5 years post procedure | 
| Technical procedure | The practices related to the use of silk vista baby will be describe | At T0 |