NCT04839705招募中不适用
Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Microvention-Terumo, Inc.58 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年8月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 58
- 主要终点
- Key Effectiveness Outcome
研究概览
简要总结
A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be ≥ 18 at the time of screening
- •Patient must have a single ruptured or unruptured IA requiring treatment
- •Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures
排除标准
- •Patient has an IA with characteristics unsuitable for endovascular treatment
- •Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
- •Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
- •Patient index IA was previously treated
- •Patient is pregnant
结局指标
主要结局
Key Effectiveness Outcome
时间窗: 12 Months
Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
Key Safety Outcome
时间窗: 12 Months
Proportion of subjects with death of any nonaccidental cause or any major stroke\* within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment
次要结局
未报告次要终点
研究者
研究点 (58)
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