NCT04044443进行中（未招募）不适用
Post Market Registry of the IMPEDE and IMPEDE-FX Embolization Plugs
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 10
- 主要终点
- Safety - Rate of freedom from serious adverse events
研究概览
简要总结
EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems
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
- •Study participant is ≥18 years of age
- •Study participant is considered a candidate for arterial or venous embolization of the peripheral vasculature
排除标准
- •Study participant has an inability to provide written informed consent
- •Study participant/treatment outside of the approved study device labeling, instructions for use (IFU)
- •Study participant is a prisoner or member of other vulnerable population
结局指标
主要结局
Safety - Rate of freedom from serious adverse events
时间窗: 30 days
Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor
Efficacy - Rate of technical success (embolization of target vessel)
时间窗: Immediately after the intervention
Technical success, defined as embolization of the target area after deployment of the study device
次要结局
- Efficacy - Rate of treated vessel occlusion(90 days)
- Safety - Rate of freedom from serious adverse events(90 days)
- Efficacy - Rate of recurrence of clinical symptoms, based on original complaint(90 days)
研究者
研究点 (10)
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