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
319
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 of the sub-dural hematoma
Surgical evacuation of the sub-dural hematoma
Primary Effectiveness Endpoint-Number of Participants With Treatment Failure
Treatment failure as defined by the occurrence of any of the following events: 1. Residual or re-accumulation of the SDH (≥10 mm) on 180-day scan from intervention. 2. Re-operation (after index procedure) or surgical rescue within 180-days of intervention. 3. Any new, major disabling stroke, myocardial infarction (MI) or death from any (neurological) cause within 180-days of intervention.
Time frame: On 180-day from intervention
Primary Safety Endpoint-Number of Participants With Major Disabling Stroke or Any Death Within 30 Days of Intervention
Major disabling stroke or any death within 30-days from intervention.
Time frame: Within 30-days from intervention
Any Investigational Device/MMAE Procedure-related AE/SAE
Number of participants with an adverse event (AE) or serious adverse event (SAE) adjudicated as probably or causally related to the investigational device or Middle Meningeal Artery Embolization (MMAE) procedure.
Time frame: Through 1-year visit
mRS Shift Analysis at 180-day Visit
The modified Rankin Scale (mRS) is an ordinal scale used to measure the degree of disability or dependence in the daily activities of people who have suffered a stroke. Scores range from 0 (no symptoms) to 6 (death): 0: No symptoms 1. No significant disability 2. Slight disability 3. Moderate disability 4. Moderately severe disability 5. Severe disability 6. Dead The Shift Analysis (also known as an ordinal analysis) evaluates the distribution of mRS scores to identify a general improvement or 'shift' across the entire range of the scale, rather than just comparing 'good' vs. 'poor' outcomes.
Time frame: 180-day from intervention
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