Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment, an Observational, Prospective, Single Arm, International, Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 234
- 试验地点
- 29
- 主要终点
- Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
Morbi-mortality of silk vista and silk vista baby in the treatment of intracranial aneurysms.
时间窗: 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.
次要结局
- Efficacy of silk vista and silk vista baby(Up to 5 years post procedure)
- Safety of silk vista and silk vista baby(At 5 years post procedure)
- Technical procedure(At T0)