Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA

Study Overview
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Brief Summary
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This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).

Detailed Description
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This is a prospective, multi-center, open-label, randomized controlled study in which up to 376 subjects will be randomized to receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of cSDH.

Official Title
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Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Device: Experimental: Interventional Cohort: Treatment Arm
* Other: Active Comparator: Interventional Cohort: Control Arm
* Device: Experimental: Observational Cohort: Treatment Arm
* Other: Active Comparator: Observational Cohort: Control Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-randomization mRS </= 3 Confirmed diagnosis of chronic subdural hematoma Completed informed consent Exclusion Criteria: Acute subdural hematoma Prior treatment of target subdural hematoma Markwalder assessment >/= 3 Glasgow Coma Scale < 9 Presumed microbial superinfection CT or MRI evidence of intracranial tumor or mass lesion Life expectancy < 1 year Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study Current involvement in another clinical trial that may confound study endpoints

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Interventional Cohort: Treatment Arm<br>Standard of Care Surgery + Embolization | Device: Experimental: Interventional Cohort: Treatment Arm<br>* Standard of Care Surgery + Embolization<br>|
| Active Comparator: Active Comparator: Interventional Cohort: Control Arm<br>Standard of Care Surgery Only | Other: Active Comparator: Interventional Cohort: Control Arm<br>* Standard of Care Surgery Only (Control)<br>|
| Experimental: Experimental: Observational Cohort: Treatment Arm<br>Standard of Care Medical Management + Embolization | Device: Experimental: Observational Cohort: Treatment Arm<br>* Standard of Care Medical Management + Embolization<br>|
| Active Comparator: Active Comparator: Observational Cohort: Control Arm<br>Medical Management Only | Other: Active Comparator: Observational Cohort: Control Arm<br>* Standard of Care Medical Management Only (Control)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Hematoma recurrence/progression or requiring re-intervention | 180 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Reduction of hematoma volume | 180 days post procedure | 
| Safety: Change in mRS | Change in mRS | 180 days post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Subdural Hematoma, MMA Embolization