NCT03467542已完成不适用
PHIL dAVF: Study of PHIL® Embolic System In The Treatment of Intracranial Dural Arteriovenous Fistulas
Microvention-Terumo, Inc.2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年8月24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
- 64
- 试验地点
- 2
- 主要终点
- Subjects With Neurological Death or Ipsilateral Stroke
研究概览
简要总结
This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material.
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
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 - 80 years.
- •Subject is willing and capable of complying with all study protocol requirements, including specified follow-up period.
- •Subject or authorized legal representative must provide written informed consent prior to initiation of any study procedures.
- •Subject has an intracranial dAVF
排除标准
- •Subject having multiple dAVFs to be treated.
- •Subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated).
- •Subject has known allergies to dimethylsulfoxide, iodine.
- •Subject is currently participating in another clinical study
- •Female subject is currently pregnant.
- •Subject has co-morbid conditions that may limit survival to less than 24 months.
结局指标
主要结局
Subjects With Neurological Death or Ipsilateral Stroke
时间窗: 30 days
Reported incidences of death or ipsilateral stroke
次要结局
- Technical Events During the PHIL Embolization Procedure(s)(During the procedure)
- Device-related Adverse Events(30 days)
研究者
研究点 (2)
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