NCT02180958已完成不适用
Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs. Prospective, Multi-center and Observational French Study
Medtronic Neurovascular Clinical Affairs17 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014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
- 140
- 试验地点
- 17
- 主要终点
- Incidence of Device or procedure Adverse Events
研究概览
简要总结
To assess safety and efficacy of ONYX treatment for cAVM:
详细描述
The main objective of this study is to assess the safety at 1 month after any embolization session and the efficacy at:
- 12 months post last embolization in case of treatment with embolization only
- 12 months after additional treatment with neurosurgery
- 36 months after additional treatment with radiosurgery
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient presents a cerebral AVM (not already treated) that can be treated by embolization with Onyx whether or not associated with a cyanoacrylate based adhesive,
- •The patient is at least 6 years old.
排除标准
- •During the treatment period for his/her cerebral AVM, the patient participates in a study assessing another medical device, another procedure or a drug.
- •The patient and/or his/her legal representative (if applicable) refuses to give his/her consent to the collection and processing of data required by the centralized follow-up. For patients who refused collection of their personal data, only, the reason for non inclusion and date of implantation will be documented.
- •Any condition that could prevent follow-up of the patient.
结局指标
主要结局
Incidence of Device or procedure Adverse Events
时间窗: 1 month
Device or procedure related adverse events
Healing rate
时间窗: 12 or 36 months
No residual early venous return * 12 months after last embolization in case of complete treatment or stopping treatment; * 12 months after additional intervention in case of additional treatment required by neuro-surgery; * 36 months after additional intervention in case of additional treatment required by radio-surgery.
次要结局
- Describe funtional independence(1 and 12 months)
研究者
研究点 (17)
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