Safety of Apollo Embolization Delivery Micro Catheter in Pediatric Patients With Vascular Malformations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The study's primary endpoint is the incidence of catheter entrapment.
研究概览
简要总结
This is a clinical trial/study for patients diagnosed with brain arteriovenous malformation (AVM). An AVM is an abnormal connection between the arteries and veins of the brain. Patients considered for this trial are 21 years and younger with AVM suitable for embolization treatment (a procedure used to block the abnormal connection between the arteries and veins of the brain) with Onyx Liquid Embolic System (Onyx LES) or TruFill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (both are liquid substances used in the embolization procedure to block the abnormal connection).
详细描述
-Why is this study being done?
The purpose of this study is to evaluate the safety of the Apollo Embolization Delivery Micro Catheter device (device that looks like a long thin hallow tube) when used in Pediatric patients with vascular malformations.
The Apollo Onyx Delivery Micro Catheter device is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Apollo Onyx™ Delivery Micro Catheter device is not approved for use in the U.S, although it is widely used and approved for use in Europe (CE0297).
This clinical study is sponsored by Dr. Alejandro Berenstein of St.Luke's-Roosevelt Hospital, New York who is also the principal Investigator of the study. Total duration of study is up to 30 months with approximately an 18 months enrollment period. Patients follow up period is up to 12 months upon enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 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.
- •Subject's age is ≤ 21 years.
- •The subject has a confirmed diagnosis of brain arteriovenous malformation in the cerebral cortex, cerebellum or dura mater that is indicated for endovascular embolization with Onyx™ LES or TruFill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic Systems and where the use of Apollo Embolization Delivery Micro Catheter may or may not be indicated for surgical resection.
- •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 with the exception of new born babies with Vein of Galen malformation with cardiopulmonary failure where no other treatment option remains.
- •The subject agrees to and is capable of completing all study required procedures
排除标准
- •Female who is pregnant or lactating.
- •Current participation in another investigational drug or device study.
- •Subject has a brain tumor or other malignancy
研究组 & 干预措施
Apollo Group
Apollo Micro catheter device
干预措施: Apollo Micro Catheter device (Device)
结局指标
主要结局
The study's primary endpoint is the incidence of catheter entrapment.
时间窗: Within 24 hours after embolization
The study's primary endpoint is the incidence of catheter entrapment. Catheter entrapment entails any part of the Apollo Micro catheter Delivery Device, excluding the catheter tip, being inadvertently left within the vasculature at the end of the procedure
次要结局
- Incidence of catheter/procedure-related adverse events.(At one year post procedure)
- Incidence of catheter/tip leakage from the detachment zone.(At one year post procedure)
- Incidence of migration of the detached catheter tip(At one year post procedure)
- Incidence of unintentional catheter tip detachment.(Within 24 hours after embolization)
- Incidence of migration of the detached catheter tip.(Within 24 hours after embolization)