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).
Inclusion Criteria:
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:
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.
Exclusion Criteria:
Candidates will be excluded from participation if ANY of the following apply:
sandy.l.alvarez@lahey.org7865800186
In this cohort, subjects will undergo either unilateral or bilateral middle meningeal artery (MMA) embolization using coils as part of their medical management for chronic subdural hematoma (cSDH). In the unilateral arm, the MMA on the side of the hematoma is embolized, while in the bilateral arm, both sides are embolized regardless of hematoma location.
In this cohort, subjects will undergo either unilateral or bilateral middle meningeal artery (MMA) embolization using coils in addition to standard surgical management for chronic subdural hematoma (cSDH). In the unilateral arm, the MMA on the side of the hematoma is embolized, while in the bilateral arm, both sides are embolized regardless of hematoma location.
Chronic Subdural Hematoma Embolization With Detachable Coils
The CHALLENGER Registry
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Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy
Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
Endovascular Embolization for Chronic Subdural Hematomas Following Surgical Evacuation
Dartmouth Middle Meningeal Embolization Trial (DaMMET)
Management of CSDH With or Without EMMA- a Randomized Control Trial