The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subd… (NCT04410146) | Clinical Trial Compass
CompletedNot Applicable
The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
United States310 participantsStarted 2020-11-01
Plain-language summary
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)
Who can participate
Age range30 Years
SexALL
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Inclusion criteria
✓. Male or female Subject whose age is ≥ 30 at the time of consent
✓. Pre-morbid mRS 0-1 within the previous 12 months
✓. cSDH measures ≥ 10 mm in greatest thickness
✓. cSDH exerts mass effect upon the subjacent brain, as indicated by local cortical flattening or midline shift
✓. Imaging characteristics indicative of chronicity (≥ 50% of the volume of the collection should be isodense or hypodense to normal cortical gray matter on Computed Tomography (CT))
✓. Subject presents with one or more of the following neurological symptoms: headache; cognitive decline; speech difficulty or aphasia; gait impairment or imbalance; focal neurological deficit (weakness, paresthesia or sensory deficit involving of one or more extremities or facial droop); and/or seizure
✓. Subject, or his/her legally authorized representative, understands the nature of the procedure, consents to participation in the study and provides a signed Informed Consent Form
✓. Female Subjects of child-bearing potential must be able to provide a current negative urine pregnancy test and agree to an appropriate method of contraception throughout the trial
Exclusion criteria
✕. Subject with prior ipsilateral craniotomy or burr hole evacuation of cSDH
✕. Subject with prior Embolization of either MMA
. Subject requires (in the opinion of the treating surgeon) a full or mini craniotomy
✕. Subject with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed
✕. Subject with a cSDH with a focal location (confined to the frontal or temporal base or the inter-hemispheric space without cerebral convexity involvement)
✕. cSDH developed due to underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or secondary to a previous craniotomy
✕. Life expectancy of \<1 year
✕. Subject who presents with an intracranial mass other than subdural hematoma