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
- 58
- 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
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
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 rate of the permanent neurologic deficits and procedure related mortality.
次要结局
- Safety of silk vista and silk vista baby(At T0)
- Safety of silk vista and silk vista baby(At hospital discharge)
- Safety of silk vista and silk vista baby(Up to 30 days (-10 / + 21 days) post- procedure.)
- Safety of silk vista and silk vista baby(At 6 months (-2/+3 months) post- procedure.)
- Safety of silk vista and silk vista baby(At 12 months (-3/+6 months) post- procedure.)
- Safety of silk vista and silk vista baby(At 3 years post procedure)
- Efficacy of silk vista and silk vista baby(At T0)
- Efficacy of silk vista and silk vista baby(At hospital discharge)
- Efficacy of silk vista and silk vista baby(Up to 30 days (-10 / + 21 days) post- procedure.)
- Efficacy of silk vista and silk vista baby(Up to 6 months (-2/+3 months) post- procedure)
- Efficacy of silk vista and silk vista baby(Up to 12 months (-3 / + 6 months) post procedure)
- Efficacy of silk vista and silk vista baby(Up to 3 years post procedure)
- 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)
研究者
研究点 (58)
标识符
- NCT 编号
- NCT04034810
- 其他研究编号
- CIP 201802 SILK VISTA
日期
- 首次提交
- (7年前)
- 首次发布
- (7年前)
- 主要完成日期
- (3年前)
- 研究完成日期
- (明年)
- 最近核实
- (去年)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否