Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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Subdural Hematoma

Intervention / Treatment
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* Procedure: Surgical Management
* Device: Surgical Management + Treatment
* Other: No Treatment
* Device: Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-morbid Modified Rankin Score ≤3 Confirmed diagnosis of subacute or chronic subdural hematoma Completed informed consent Meets criteria for Surgery or Observation Cohort Exclusion Criteria: 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

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: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery Cohort: Control Arm<br>Control | Procedure: Surgical Management<br>* SDH Evacuation (Control)<br>|
| Experimental: Surgery Cohort: Treatment Arm<br>Treatment | Device: Surgical Management + Treatment<br>* SDH Evacuation + Onyx™ LES Embolization<br>|
| Active Comparator: Observational Cohort: Control Arm<br>Control | Other: No Treatment<br>* Observation Only (Control)<br>|
| Experimental: Observational Cohort: Treatment Arm<br>Treatment | Device: Treatment<br>* Onyx™ LES Embolization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: Incidence of hematoma recurrence/progression requiring re-intervention |  | 90 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 hematoma thickness per CT/MRI imaging |  | 90 days post-procedure | 
| Effectiveness: Change in midline shift based on CT/MRI imaging |  | 90 days post-procedure | 
| Safety: Incidence of device-related serious adverse events |  | 30 days post-procedure | 
| Safety: Incidence of procedure-related serious adverse events |  | 30 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 |