NCT02335788已完成不适用
EMBA Peripheral Embolization Device ("EPED") Study
EMBA Medical, Inc.2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Target vessel occlusion (assessed by CTA)
研究概览
简要总结
This is an open label, acute, non-randomized, prospective, "first in man" (FIM) single-center study of the EMBA Medical Peripheral Embolization Device (PED).
详细描述
This study is a FIM, open label, prospective, single center, non-randomized, evaluation of the EMBA Medical Peripheral Embolization Device (PED) used for arterial or venous embolization in the peripheral 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
- 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
- •The patient is >18 years of age.
- •Patient is considered a candidate for arterial or venous embolization in the peripheral vasculature.
- •Patient has a target vessel diameter of 3-8mm and a target PED landing zone of greater than 25mm wherein the vessel diameter is between 3 and 8 mm.
- •The patient or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent.
- •The patient has suitable vessel anatomy that would allow proper placement of the PED.
排除标准
- •The patient has one of the following conditions:
- •1.1 Arterio-venous fistula 1.2 Hypercoagulability 1.3 Systemic coagulopathy 1.4 Connective tissue disorder such as Ehlers-Danlos Syndrome 1.5 Congenital arteritis such as Takayasu's Disease 1.6 Other circulatory disorders at the discretion of the implanting physician
- •The patient has an uncontrolled infectious disease.
- •The patient has a life expectancy of less than 6 months.
- •The patient is pregnant.
- •The patient has a condition that inhibits radiographic visualization of the PED.
- •The patient has a known allergy or intolerance to Nitinol.
- •The patient has a known hypersensitivity to contrast that cannot be pre-treated.
- •The patient's access vessels preclude safe insertion of the delivery system.
- •The patient is currently participating in another device or drug study.
结局指标
主要结局
Target vessel occlusion (assessed by CTA)
时间窗: 30 Days
vessel occlusion as assessed by CTA
次要结局
未报告次要终点
研究者
研究点 (2)
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