NCT01793792已完成不适用
Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS
Microvention-Terumo, Inc.41 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 41
- 主要终点
- Primary Effectiveness Composite Success "Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment"
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age between 18 and 75 years
- •Subject with an unruptured or ruptured(>30days since occurence), wide-necked (neck ≥4mm or dome to neck ratio <2)intracranial saccular aneurysm (<20mm maximum diameter in any plane)
排除标准
- •Subject with significant extra or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm.
- •Subject with any condition which in the opinion of the treating physician would place the subject at high risk of embolic stroke
- •Subject with contraindications to the use of antiplatelet agents
- •Subject who is unable to complete the required follow-up
结局指标
主要结局
Primary Effectiveness Composite Success "Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment"
时间窗: 12 months
Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (41)
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