The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)

Completed · Not applicable

Conditions studied: Subdural Hematoma, Chronic

In brief

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)

Key facts

Study ID

NCT04410146

Run by

Balt USA

People needed

319

Starts

2020-11-01

Expected to finish

2024-05-23

Last updated by the study team

2026-06-04

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female Subject whose age is ≥ 30 at the time of consent
• Pre-morbid mRS (Modified Rankin Scale) 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
• Subject is able and willing to return to the investigational site for all follow-up visits (e.g., 30-day, 90-day, 180-day and 1-year), as required per protocol

You may not qualify if…

• 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
• Subject who presents with a meningioma with mass effect and/or ≥1 cm or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
• Subject with serum creatinine level > 3.0 mg/dL at time of enrollment (this will restrict the use of contrast) and not on dialysis
• Subject with significant liver function impairment at the time of enrollment
• Subject with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)
• Subject who is currently enrolled in another investigational study protocol that could potentially confound the current study endpoints

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• Carondolet St. Joseph's — Tucson, Arizona, United States
• Riverside Community Hospital — Riverside, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• Los Robles Hospital and Medical Center — Thousand Oaks, California, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Baptist Health — Jacksonville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Wellstar Kennestone Hospital — Marietta, Georgia, United States
• University of Kansas — Kansas City, Kansas, United States
• Johns Hopkins Medicine — Baltimore, Maryland, United States
• Nebraska Health — Omaha, Nebraska, United States
• Overlook Medical Center — Summit, New Jersey, United States
• NYU Langone Health — New York, New York, United States
• Stony Brook University — Stony Brook, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Penn State Health Hershey Medical Center — Hershey, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Methodist University Hospital — Memphis, Tennessee, United States
• Baptist Memorial Hospital — Memphis, Tennessee, United States
• University of Utah — Salt Lake City, Utah, United States
• Swedish Cherry Hill — Seattle, Washington, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.