Comparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization
2026年8月5日 更新者：Sanford Health
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.
研究概览
地位
尚未招聘
详细说明
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).
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Alycia Abler Clinical Research Project Manager
- 电话号码：(701) 417-2002
- 邮箱：alycia.abler@sanfordhealth.org
学习地点
-
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South Dakota
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Sioux Falls、South Dakota、美国、57105
- Sanford USD Medical Center
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
Participants will be sequentially enrolled into one of three clinically accepted MMAE treatment strategies (interventions) to compare radiographic and clinical outcomes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in hematoma size
大体时间：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.
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Baseline, 90 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Complications
大体时间：Baseline, 90 days
|
The secondary objectives aim to evaluate the safety profile of the embolic materials, to support overall comparative effectiveness.
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Baseline, 90 days
|
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Recurrence Rates
大体时间：Baseline, 90 days
|
The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.
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Baseline, 90 days
|
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Adverse Events
大体时间：Baseline, 90 days
|
The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.
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Baseline, 90 days
|
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Re-Intervention Rates
大体时间：Baseline, 90 days
|
The secondary objectives aim to evaluate the the safety profile of the embolic materials, to support overall comparative effectiveness.
|
Baseline, 90 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年9月1日
研究完成 (估计的)
2028年3月1日
研究注册日期
首次提交
2026年7月31日
首先提交符合 QC 标准的
2026年8月5日
首次发布 (实际的)
2026年8月11日
研究记录更新
最后更新发布 (实际的)
2026年8月11日
上次提交的符合 QC 标准的更新
2026年8月5日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.