This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to either initial surgical evacuation (Control Arm) or initial MMAE with PHIL™ (investigational arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
475
Embolization of MMA with PHIL.
Surgical evacuation of cSDH.
Primary Safety Endpoint
Incidence of mRS 0-2.
Time frame: 90 days post procedure
Primary Effectiveness Endpoint
Incidence of clinically indicated (as adjudicated by CEC) surgical evacuation of the target cSDH among subjects in the PHIL™ MMAE arm.
Time frame: 90 days post procedure
Death or major disabling stroke.
Time frame: 30-, 90-, and 180-days post-index procedure
The composite of: recurrent or residual chronic subdural hematoma on the target side measuring ≥ 10 mm; retreatment; or major disabling stroke, myocardial infarction, or death from neurologic causes.
Time frame: 180 days post procedure
Resolution of cSDH without retreatment.
Time frame: 90- and 180-days post procedure
Neurological death
Time frame: 90- and 180-days post procedure
Change in EQ-5D-5L from baseline
Time frame: 90- and 180-days post procedure
cSDH-related hospital re-admissions and re-admission days
Time frame: 90- and 180-days post procedure
Index hospitalization length of stay
Time frame: post procedure
Neurological Events of Interest: minor stroke, major stroke, cSDH expansion, acute cSDH, mRS deterioration of 2 points or greater
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Time frame: 90 days and 180 days post procedure