MMA Embolization With NeoCast for Subacute and Chronic Subdural Hematoma

Inclusion Criteria

• Participant whose age is ≥ 18 and ≤ 90 years;
• Pre-morbid mRS ≤ 2;
• Confirmed diagnosis of subacute or chronic subdural hematoma that measures ≥10 mm in greatest thickness;
• Participant presents with one or more of the following corroborating neurological symptoms: headache; cognitive decline; speech difficulty; gait impairment or imbalance; focal neurological deficit; and/or seizure, within the last 30 days;
• Participant is planned for middle meningeal artery embolization within ±7 days of surgical evacuation of hematoma via burr hole or craniotomy;
• Participant or Legally Authorized Representative/Person Responsible for consenting on their behalf understands the nature of the procedure, consents to participation in the study and provides a signed informed consent form;
• Participant (woman of child-bearing potential) with a current negative pregnancy test who has agreed to an appropriate method of contraception throughout the trial;
• Participant is willing to return to the investigational site for follow-up visits.

Exclusion Criteria

• Diagnosed with acute SDH
• Participant with prior embolization of either MMA
• Participant with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed
• Participant with bilateral SDH where both sides require surgery or contralateral SDH >5mm in greatest thickness
• Participant identified with potentially dangerous anatomic variations leading to increased procedural risk, risk of incomplete embolization, or unsafe access for MMA embolization (i.e., MMA originating from ophthalmic artery)
• Participant who presents with a meningioma ≥1 cm or \< 1 cm with mass effect
• Subjects with conditions placing them at high-risk for ischemic stroke who cannot be taken off anticoagulants for at least 7 days post-surgery
• Participant currently undergoing radiation therapy for carcinoma or sarcomas of the head or neck region
• SDH developed due to underlying condition or structure pathology (e.g., dural AV fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt, spontaneous intracranial hypotension or previous craniotomy)
• Presumed microbial superinfection
• Participant who is breastfeeding
• Participant with life expectancy of \<1 year
• Participants with acute renal impairment that the investigator assesses could be at risk for contrast induced nephropathy
• Participant with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)
• Participant is allergic to any of the materials used in the NeoCast device or the Onyx LES commercial embolic device
• Participant who is currently participating or planning to participate within 6 months in another clinical research study