Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas: A Randomized Controlled Trial.
This is a pragmatic, prospective, multicenter, randomized controlled trial with intention to treat analysis. In which subjects will receive either unilateral or bilateral middle meningeal artery (MMA) embolization using coils for the treatment of unilateral chronic subdural hematomas (cSDH).
‣ Candidates for this study must meet ALL of the following criteria:
• Subject is 18 years of age or older.
• Subject has a diagnosis of chronic subdural hematoma with mass effect Determined by brain imaging (CT or MRI) and correlated clinical symptoms.
• Pre-randomization modified Rankin Score (mRS) ≤3
• a. Surgical Cohort: Assessment should reflect the subject's condition just prior to undergoing surgery. Assessment may be performed post-surgery using pre-surgical data.
• Subdural Hematoma Size
• Medical Management Cohort:
⁃ Midline shift \< 10mm and hematoma thickness \> 10 mm as measured on coronal imaging perpendicular to the skull.
⁃ No focal deficit related to the chronic subdural hematoma requiring surgical intervention
• Surgical Cohort:
• • No requirement
• A CT performed prior to randomization demonstrating stability of the hematoma. Stability is defined as no worsening of midline shift or increase in the size of the cSDH from the screening image that results in new or worsening clinical symptoms.
• Patient or designated Legal Authorized Representative, confirms the patient has the mental capacity, willingness and ability to comply with protocol and follow-up requirements
• In the opinion of the treating physician, MMA embolization is technically feasible, including evaluation of preoperative CTA, if available, or presence of a foramen spinosum bilaterally.