Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 4
- 主要终点
- Number of Participants With Catheter-related Adverse Events at 30 Days
研究概览
简要总结
The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous malformation (AVM) embolization procedures.
详细描述
This study is a prospective, single-arm, multicenter, post-market safety evaluation of subjects indicated for embolization of brain AVMs with the study device. The study device was developed to potentially minimize the side effects of catheter retainment and increased procedural risk associated with alternative methods necessary for removing entrapped catheters. In the event of catheter retainment, using the Apollo™ Onyx™ Delivery Microcatheter versus any a standard catheter represents leaving behind a 1.5 - 3.0 cm long detachable tip in the Onyx™ Onyx™ Delivery Microcatheter cast versus an average 165 cm long catheter in the vasculature.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Subject or Subject's legally authorized representative has signed and dated an informed consent form.
- •The Subject has a confirmed diagnosis of a brain AVM.
- •The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization.
- •The Subject has a life expectancy of at least 1 year.
- •The Subject agrees to and is capable of completing all study-required procedures.
排除标准
- •Current participation in another investigational drug or device study that evaluates treatments for brain AVMs or other cerebrovascular disease.
- •The Subject has a bleeding disorder.
- •The Subject is not a candidate for the use of vasodilators.
研究组 & 干预措施
AVM treatment
Apollo™ Onyx™ Delivery Micro Catheter
干预措施: Apollo™ Onyx™ Delivery Micro Catheter (Device)
结局指标
主要结局
Number of Participants With Catheter-related Adverse Events at 30 Days
时间窗: 30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Premature (unintentional) catheter tip detachment with clinical sequelae Catheter rupture/break/fracture with clinical sequelae Retained catheter body in the vasculature
次要结局
- Number of Participants With Intentional Catheter Tip Detachment at 30 Days(30 days)
- Number of Participants With Catheter-related Adverse Events at 30 Days(30 days)
- Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days(30 days)
- Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days(30 days)
- Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months(12 months)
- Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days(30 days)
- Number of Participants With Catheter-related Adverse Events at 12 Months(12 months)