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

Inclusion Criteria:

• Male or female Subject whose age is ≥ 30 at the time of consent
• Pre-morbid mRS 0-1
• 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
• Subject presents with one or more of the following neurological symptoms: headache; cognitive decline; speech difficulty or Aphasia; gait impairment or imbalance; focal neurological; and/or seizure
• 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

Exclusion Criteria:

• Subject with prior craniotomy or burr hole evacuation of cSDH
• 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 < 10 mm in thickness
• cSDH without associated mass effect (no cortical flattening or midline shift)
• .< 50% volume of the blood collection is isodense or hypodense to normal cortical gray matter
• cSDH developed due to underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or secondary to a previous craniotomy
• 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