The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
STEM
1 other identifier
interventional
319
4 countries
32
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Longer than P75 for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2020
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2024
CompletedResults Posted
Study results publicly available
June 4, 2026
CompletedJune 4, 2026
June 1, 2026
3.6 years
May 27, 2020
February 26, 2026
June 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Within 30-days from intervention
Secondary Outcomes (2)
Any Investigational Device/MMAE Procedure-related AE/SAE
Through 1-year visit
mRS Shift Analysis at 180-day Visit
180-day from intervention
Other Outcomes (8)
mRS ≤ 2 (Binary)
180 days
Global Neurocognitive Performance
Baseline and 180 Days
EQ-5D-5L (Including EQ-VAS) Visual Analogue Scale
180-day change from Baseline
- +5 more other outcomes
Study Arms (2)
SQUID
EXPERIMENTALEmbolization of the Middle Meningeal Artery (MMA)
No Embolization
ACTIVE COMPARATORStandard Management For subjects in the surgery only group (i.e., surgical management but no adjunctive MMAE), the surgical evacuation was to occur within 48 hours of randomization. Surgery included hemorrhage evacuation through one or two burr-holes with irrigation of the hematoma (and the option for placement of a subgaleal or subdural drain) or twist-drill drainage, such as Subdural Evacuating Port System. Subjects in the non-surgical management alone group were followed by the clinical team and treated as per the standard of care (SOC) established at the institution for the management of cSDH. Standard of care typically included cSDH monitoring, medical intervention to control symptoms, reversal or cessation of anti-coagulant and anti-platelet medications as well as the administration of anti-inflammatory medications (e.g., steroids, statins).
Interventions
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
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Balt USAlead
Study Sites (32)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Carondolet St. Joseph's
Tucson, Arizona, 85711, United States
Riverside Community Hospital
Riverside, California, 92501, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, 92360, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Baptist Health
Jacksonville, Florida, 32207, United States
Emory University
Atlanta, Georgia, 30322, United States
Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
University of Kansas
Kansas City, Kansas, 66160, United States
Johns Hopkins Medicine
Baltimore, Maryland, 21287, United States
Nebraska Health
Omaha, Nebraska, 68106, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
NYU Langone Health
New York, New York, 10016, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Penn State Health Hershey Medical Center
Hershey, Pennsylvania, 17918, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Swedish Cherry Hill
Seattle, Washington, 98122, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Chu Cote de Nacre
Caen, 14000, France
CHU Hopital Bicetre
Le Kremlin-Bicêtre, 94275, France
Hopital Pitie Salpetriere
Paris, France
CHU Hopital Maison Blanche
Reims, France
Universitätsklinikum Heidelberg
Heidelberg, Germany
Klinikum Nurnberg Sud
Nuremberg, Germany
Gregorio Maranon Hospital
Madrid, 28007, Spain
Related Publications (1)
Fiorella D, Monteith SJ, Hanel R, Atchie B, Boo S, McTaggart RA, Zauner A, Tjoumakaris S, Barbier C, Benitez R, Spelle L, Pierot L, Hirsch JA, Froehler M, Arthur AS; STEM Investigators. Embolization of the Middle Meningeal Artery for Chronic Subdural Hematoma. N Engl J Med. 2025 Feb 27;392(9):855-864. doi: 10.1056/NEJMoa2409845. Epub 2024 Nov 20.
PMID: 39565980DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Evidence
- Organization
- Balt USA
Study Officials
- PRINCIPAL INVESTIGATOR
David Fiorella, MD, PhD
Stony Brook University Medical Center
- PRINCIPAL INVESTIGATOR
Adam Arthur, MD, MPH
Semmes-Murphy Neurologic and Spine Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neurocognitive battery. Imaging assessment by blinded core laboratory
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2020
First Posted
June 1, 2020
Study Start
November 1, 2020
Primary Completion
May 23, 2024
Study Completion
May 23, 2024
Last Updated
June 4, 2026
Results First Posted
June 4, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share