Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 12
- 主要终点
- Morbidity and Mortality associated with stenting and coiling
研究概览
简要总结
This is a prospective observational multicenter registry to evaluate safety and efficacy data on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an intent to treat basis.
The objectives of this study are:
- Assessment of morbidity-mortality at 1 month and 12-18 months following the treatment of the intracranial aneurysm with Neuroform3TM stent and endovascular coiling using the modified Rankin scale (mRS).
- to evaluate adverse events.
- Angiographic assessment at 12-18 months compared to the initial post-treatment assessment via the modified Raymond scale and same/better/worse scale.
详细描述
There is an increasing perception in the Neurovascular community - supported by extensive peer-to-peer and congress communications - that "stent-assisted coiling" of intracranial wide neck aneurysms improves the long term angiographic outcome of treated patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •18 year's old patient or above.
- •every patient suffering from an un-ruptured or ruptured aneurysm, for whom the endovascular treatment approach using the Neuroform3TM stent is considered by the therapeutic team in charge.
- •patient who has given his consent to participate to the study and to get his anonymized data collected
排除标准
- •patient with dissecting or fusiform aneurysm
- •treatment of several aneurysms in the same procedure, except adjacent aneurysm treated by the same stent
- •severe vasospasm
- •aneurysm associated with an arterio-venous malformation
- •use of another Neuroform3TM stent
- •woman pregnant or nursing
- •patients not likely to be followed upon (living abroad)
- •people protected by justice (safeguard of law, supervision or trusteeship)
- •patient unsuitable to the anti-thrombotic and/or to anticoagulants therapies
结局指标
主要结局
Morbidity and Mortality associated with stenting and coiling
时间窗: 30 days and 12-18 months post procedure
Assessment of morbidity and mortality at 30 days and 12-18 months post endovascular treatment of wide neck aneurysm with a Neurform 3 stent and coiling as assessed by the modified Rankin scale (mRS).
次要结局
- Efficacy of the Neuroform stent for treatment of wide neck aneurysms(post procedure and at 12-18 months post procedure)