NCT00288405已完成1 期
Cordis Neurovascular Feasibility Study of the Enterprise Self-Expanding Stent System to Facilitate Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms
Codman & Shurtleff2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2004年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Successful stent placement with satisfactory coil mass position angiographically.
研究概览
简要总结
To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent System to facilitate endovascular coil embolization of wide neck saccular intracranial aneurysms.
Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel
详细描述
This is a multi-center, prospective, non-randomized feasibility study including 30 subjects. Subjects will receive a safety follow-up evaluation at 30 days (+ two weeks) and an efficacy follow-up evaluation at 6 months (+ four weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with intracranial, wide-neck, saccular aneurysms
排除标准
- •Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage
结局指标
主要结局
Successful stent placement with satisfactory coil mass position angiographically.
时间窗: immediately after post procedure
次要结局
未报告次要终点
研究者
研究点 (2)
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