The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)

Study Overview
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Brief Summary
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STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH)

Detailed Description
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The study objective is to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH).

Official Title
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The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)

Conditions
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Subdural Hematoma, Chronic

Intervention / Treatment
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* Device: SQUID Embolization
* Device: SQUID Embolization and Surgical Evacuation
* Procedure: Surgical Evacuation
* Other: Other: Medical Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Subject whose age is ≥ 30 at the time of consent Pre-morbid mRS 0-1 within the previous 12 months cSDH measures ≥ 10 mm in greatest thickness cSDH exerts mass effect upon the subjacent brain, as indicated by local cortical flattening or midline shift Imaging characteristics indicative of chronicity (≥ 50% of the volume of the collection should be isodense or hypodense to normal cortical gray matter on Computed Tomography (CT)) Subject presents with one or more of the following neurological symptoms: headache; cognitive decline; speech difficulty or aphasia; gait impairment or imbalance; focal neurological deficit (weakness, paresthesia or sensory deficit involving of one or more extremities or facial droop); and/or seizure Subject, or his/her legally authorized representative, understands the nature of the procedure, consents to participation in the study and provides a signed Informed Consent Form Female Subjects of child-bearing potential must be able to provide a current negative urine pregnancy test and agree to an appropriate method of contraception throughout the trial Subject is able and willing to return to the investigational site for all follow-up visits (e.g., 30-day, 90-day, 180-day and 1-year), as required per protocol Exclusion Criteria: Subject with prior ipsilateral craniotomy or burr hole evacuation of cSDH Subject with prior Embolization of either MMA Subject requires (in the opinion of the treating surgeon) a full or mini craniotomy Subject with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed Subject with a cSDH with a focal location (confined to the frontal or temporal base or the inter-hemispheric space without cerebral convexity involvement) cSDH developed due to underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or secondary to a previous craniotomy Life expectancy of <1 year Subject who presents with an intracranial mass other than subdural hematoma Subject who presents with a meningioma with mass effect and/or ≥1 cm or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region Subject with serum creatinine level > 3.0 mg/dL at time of enrollment (this will restrict the use of contrast) and not on dialysis Subject with significant liver function impairment at the time of enrollment Subject with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically) Subject who is currently enrolled in another investigational study protocol that could potentially confound the current study endpoints

Ages Eligible for Study
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Minimum Age: 30 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: SQUID<br>Embolization of the Middle Meningeal Artery (MMA) | Device: SQUID Embolization<br>* Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent<br>Device: SQUID Embolization and Surgical Evacuation<br>* Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent and the surgical evacuation of the sub-dural hematoma<br>|
| Active Comparator: No Embolization<br>Standard Management | Procedure: Surgical Evacuation<br>* Surgical evacuation of the sub-dural hematoma<br>Other: Other: Medical Management<br>* Standard<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | Treatment failure is defined by the occurrence of residual or re-accumulation of the SDH (≥10 mm) on 180-day scan from intervention. | On 180-day from intervention | 
| Primary Effectiveness Endpoint | Treatment failure is defined by the occurrence of any of the following events: Re-operation (after index procedure) or surgical rescue Any new, major disabling stroke, myocardial infarction (MI) or death from any (neurological) cause | Within 180-days of intervention | 
| Primary Safety Endpoint | Major disabling stroke or any death | Within 30-days from intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS (analyzed as shift) |  | 180-day from intervention | 
| Any investigational device/procedure-related AE/SAE |  | Through 1-year visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningeal Arteries, Intracranial Subdural Hematoma