NCT04402632已完成不适用
A Study of the Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System In the Treatment of Subacute and Chronic Subdural HEmatoma (EMBOLISE)
Medtronic Neurovascular Clinical Affairs98 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年10月27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
- 600
- 试验地点
- 98
- 主要终点
- Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-morbid Modified Rankin Score ≤3
- •Confirmed diagnosis of subacute or chronic subdural hematoma
- •Completed informed consent
- •Meets criteria for Surgery or Observation Cohort
排除标准
- •Life expectancy <1 year
- •Unable to complete follow-up
- •Pregnant, lactating, or has a positive pregnancy test at time of admission
- •Diagnosed with acute SDH
- •Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization
- •Pre-randomized Markwalder Grading Scale score ≥ 3
- •Unmanaged, uncontrolled bleeding disorders/blood diathesis
- •Presumed septic embolus, or suspicion of microbial superinfection
- •Known active COVID-19 infection
- •CT or MRI evidence of intra-cranial tumor or mass lesion Contraindication to angiography
- •Participation in another clinical trial
- •Contraindicated for the use of Onyx™ LES
- •Cannot be taken off corticosteroids (intended to treat subacute or chronic SDH) for at least 90 days post-randomization
结局指标
主要结局
Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline
时间窗: 90 days post-procedure
次要结局
- Safety: Incidence of procedure-related serious adverse events(30 days post-procedure)
- Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score(90 days post-procedure)
- Safety: Incidence of neurological death(90 days and 180 days post-procedure)
- Safety: Incidence of device-related adverse events(90 days and 180 days post-procedure)
- Effectiveness: Change in hematoma thickness per CT/MRI imaging(90 days post-procedure)
- Safety: Incidence of device-related serious adverse events(30 days post-procedure)
- Effectiveness: Incidence of hospital readmissions(90 days post-procedure)
- Effectiveness: Change in hematoma volume based on CT/MRI imaging(90 days post-procedure)
- Effectiveness: Change in midline shift based on CT/MRI imaging(90 days post-procedure)
研究者
研究点 (98)
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