Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma

Study Overview
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Brief Summary
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The study evaluates the clinical and imaging outcome of middle meningeal artery (MMA) embolization with liquid embolic agent for treatment of chronic subdural hematoma (CSDH)

Detailed Description
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This study is a prospective one arm trial designed to assess the safety and efficacy of MMA embolization with liquid embolic agents (onyx/squid/Phil) as the main treatment of CSDH. The subjects are enrolled in the study according to inclusion and exclusion criteria. Imaging and clinical presentations of patients are recorded. Within 48 hours of embolization, patients are assessed with clinical examination and with a brain CT scan to evaluate in any change in their symptoms and CSDH volume. 2-4 weeks after embolization, patients are evaluated in clinic for any change in their symptoms and signs. 60 days after embolization patients are examined clinically and are assessed for SDH volume change in CT scan and MRI. If there is any significant increase in CSDH volume or any deterioration of patient, evacuation of hematoma is considered. MMA embolization is performed under general anesthesia using biplane or monoplane angiography. Femoral or radial accesses are used. Guiding catheter is advanced into external carotid artery in corresponding side. The corresponding MMA is catheterized distally by micro-catheter and is embolized by liquid embolic agents. Patients are discharge next day if they are stable.

Official Title
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Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Procedure: Embolization of MMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients diagnosed chronic or subacute subdural hematoma Patients had symptoms/signs associated with chronic or subacute subdural hematoma: severe headache, hemiparesis/monoparesis, dementia, aphasia/dysphasia, loss of consciousness, ... Asymptomatic large chronic/subacute hematoma after 6-8 weeks of failed conservative treatment Exclusion Criteria: presentation with coma (GCS =< 8) patients needs emergent evacuation of hematoma, patients could not participate in 60 days follow-up pregnant patients acute subdural hematoma contraindication to contrast contradiction to angiography difficult access to MMA due to anatomical variation contraindication to liquid embolic agent unmanaged/uncontrollable bleeding disorders

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embolization arm<br>Intervention: Embolization of middle meningeal artery Device: Onyx, squid, Phil | Procedure: Embolization of MMA<br>* embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil)<br>* Other names: Phil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CSDH regression | Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization | 60 dyas | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CSDH progression or recurrence | Increase in volume of CSDH | 60 days | 
| Incidence of new neurological deficit (ND) | ND includes: dementia, memory loss, cognitive problems, monoparesis/hemiparesis, cranial nerve paresis, dysphasia/aphasia | 60 days | 
| incidence of Death |  | 60 days | 
| Incidence of new ischemic stroke | new ischemia in imaging (DWI/MRI or CT scan) within 60 days of operation | 60 days | 
| Incidence of myocardial infarction/myocardial ischemia | new ischemic heart attack within 60 days of operation | 60 days | 
| Incidence of embolization complication in brain | cranial nerve palsy (especially VII), vision loss (ophthalmic/retinal artery occlusion), ... | 48 hours | 
| incidence of embolization complication out of brain | puncture hematoma, major artery dissection, new renal failure, ... | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic subdural hematoma, embolization, middle meningeal artery, liquid embolic agent