Safety and Efficacy of i-ED Coil and EDG v4 for Arteriovenous Malformation - A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Post-procedural AVM Occlusion Assessed by Angiography or MRI
研究概览
简要总结
This is a prospective, multicenter, post-market clinical follow-up (PMCF) study to collect safety and performance data in patients with arteriovenous malformations (AVMs) who undergo endovascular coil embolization using the i-ED Coil and Electro Detach Generator v4 (EDG v4).
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 to <80 years
- •Subjects requiring endovascular treatment using coils for arteriovenous malformation
- •Free and informed consent to participate in the investigation obtained from the subject or an acceptable subject representative
排除标准
- •Coiling or stenting performed on the non-target lesion within 30 days prior to treatment of the target lesion
- •Hunt and Hess score of 3 or higher or modified Rankin Score (mRS) of 4 or higher
- •Subjects with contraindications to CT or MRI procedures
- •Subjects with contraindications to angiography procedures
- •Pregnant or breastfeeding subjects
结局指标
主要结局
Post-procedural AVM Occlusion Assessed by Angiography or MRI
时间窗: 12, 36, 60 months
Complete or partial obliteration of AVMs assessed by angiography or MRI.
Successful Coil Embolization Assessed by Angiography
时间窗: 12, 36, 60 months
Reduced blood flow to target vessels following coil embolization, assessed by angiography.
The Frequency of Detachment of Coils During Treatment Procedure
时间窗: Periprocedural
Frequency of successful coil detachment using the EDG v4 during the treatment procedure.
次要结局
未报告次要终点