Comparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in hematoma size
研究概览
简要总结
Single site, prospective, comparative effectiveness pilot trial comparing efficacy and safety outcomes of three embolic materials (particles, liquid embolics, and Wallaby Phenox coils) in MMA embolication for cSDH.
详细描述
Participants will be sequentially enrolled into one of three treatment arms based on the embolic material used during their MMA embolization:
Cohort/Arm 1: Particles (polyvinyl alcohol or similar microspheres) Cohort/Arm 2: Liquid embolics (Onyx, n-BCA, or equivalent) Cohort/Arm 3: Phenox coils (Avenir UNO Helical Coil) Participants will remain on study through their standard 30- and 90-day follow-up visits.
With a target of 30 patients (10 per arm), the study will provide preliminary data on radiographic efficacy (primary: hematoma resolution/thickness reduction), safety (complications, recurrence, adverse events, reinterventions), and exploratory outcomes (symptom/functional improvement, procedural metrics, influence of comorbidities/antithrombotics).
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
- •Adult patients (≥ 18 years)
- •Undergoing Middle Meningeal Artery Embolization (MMAE) for chronic subdural hematoma (cSDH)
- •Able to provide informed consent or have a legally authorized representative (LAR) do so
排除标准
- •Ineligible for MMAE procedure, as deemed by the treating physician, for any indication (e.g. pregnancy)
- •Non-chronic subdural hematoma (cSDH) indications for Middle Meningeal Artery Embolization (MMAE), including acute subdural hematoma with symptom onset < 72 hours or mixed acute/chronic without predominant chronic features
- •Pregnancy or breastfeeding
- •Known severe allergy or contraindication to embolic materials (e.g. particles, liquids like Onyx/n-BCA, or coils)
- •Inability to undergo angiography (e.g. severe renal impairment contraindicating contrast)
- •Inability or unwillingness to complete follow-up visits at 30 and 90 days
研究组 & 干预措施
MMA Embolization
Participants will be sequentially assigned one of three MMAE treatment strategies (particles, liquid embolics, or coils) in the order they become eligible and agree to participate. Radiographic and clinical outcomes will be compared.
干预措施: Particles (polyvinyl alcohol or similar microspheres) (Device)
MMA Embolization
Participants will be sequentially assigned one of three MMAE treatment strategies (particles, liquid embolics, or coils) in the order they become eligible and agree to participate. Radiographic and clinical outcomes will be compared.
干预措施: Liquid Embolics (Onyx, n-BCA, or equivalent) (Device)
MMA Embolization
Participants will be sequentially assigned one of three MMAE treatment strategies (particles, liquid embolics, or coils) in the order they become eligible and agree to participate. Radiographic and clinical outcomes will be compared.
干预措施: Phenox Coils (Avenir UNO Helical Coil) (Device)
结局指标
主要结局
Change in hematoma size
时间窗: Baseline, 90 days
The primary objective aims to compare the radiographic efficacy of three embolic materials (particles, liquid embolics, Phenox coils) in MMA embolization for cSDH to evaluate change in hematoma size.
次要结局
- Complications(Baseline, 90 days)
- Recurrence Rates(Baseline, 90 days)
- Adverse Events(Baseline, 90 days)
- Re-Intervention Rates(Baseline, 90 days)