STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH)
The study objective is to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
310
Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent
Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent and the surgical evacuation of the sub-dural hematoma
Surgical evacuation of the sub-dural hematoma
Primary Effectiveness Endpoint
Treatment failure is defined by the occurrence of residual or re-accumulation of the SDH (≥10 mm) on 180-day scan from intervention.
Time frame: On 180-day from intervention
Primary Effectiveness Endpoint
Treatment failure is defined by the occurrence of any of the following events: * Re-operation (after index procedure) or surgical rescue * Any new, major disabling stroke, myocardial infarction (MI) or death from any (neurological) cause
Time frame: Within 180-days of intervention
Primary Safety Endpoint
Major disabling stroke or any death
Time frame: Within 30-days from intervention
mRS (analyzed as shift)
Time frame: 180-day from intervention
Any investigational device/procedure-related AE/SAE
Time frame: Through 1-year visit
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