NCT02180945已完成不适用
ONYX Evaluation in the Endovascular Treatment of Intracranial Dural Arteriovenous Fistulae. A French, Observational, Prospective, Multicentric, Single Arm and Open Study
Medtronic Neurovascular Clinical Affairs1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2013年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Neurological clinical evolution
研究概览
简要总结
The objective of this study is to evaluate the safety and performance post last embolization with Onyx
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has an intracranial dAVF which could be treated by ONYX embolization, whether or not associated to other embolization products.
- •The patient is at least 18 years of age.
排除标准
- •The patient needs to be treated for the dAVF with another treatment option (for example by surgery) than embolization within a period of less than 6 months (to be counted as from the first treatment)
- •The patient participates to another clinical study during the treatment period for his/her dAVF, evaluating another medical devices, procedure or medication.
- •The patient refuses to give consent to the collection and processing of data required for centralized monitoring.
- •A condition which could jeopardize follow-up of the patient.
结局指标
主要结局
Neurological clinical evolution
时间窗: 1Month post procedure
Improved, Stable, Worsened, death
Healing rate
时间窗: 3-6 months post procedure
Number of patients with No residual early venous return
次要结局
- Adverse event(3-6 months after procedure)
- Quality of life EQ-5D(pre-procedure and at 3-6 months)
- Describe functional independence(1 and 12 months after procedure)
- Technical performance of the product(12 months after procedure)
研究者
研究点 (1)
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