Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Performance Measure
研究概览
简要总结
This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are over 18 years of age.
- •Patients will undergo catheter embolization using the Kaneka ED Coil with the ED Detach Generator v4 for aneurysm, arteriovenous malformation (AVM), or arteriovenous fistula (AFV)
- •The patient, or his/her representative, has agreed to the informed consent.
排除标准
- •The patient, or his/her representative, is unwilling or unable to agree to the informed consent.
结局指标
主要结局
Performance Measure
时间窗: At 12 months
The recanalization in aneurysms will be classified using the Raymond-Roy Classification. The outcomes following embolization of arteriovenous malformations and arteriovenous fistula will be classified as follows complete occlusion/subtotal occlusion/ partial occlusion
Safety Measure - Assessment of Adverse Events
时间窗: During 12 months
All adverse events will be recorded, along with their seriousness and relatedness to the device or the procedure.
Technical Measure
时间窗: At embolization procedure, an average of 1 week
The technical properties of the ED Electrodetach Generator v4 will be assessed by the the number of detachment attempts
次要结局
未报告次要终点