The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
NCT ID: NCT04410146
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
310 participants
INTERVENTIONAL
2020-11-01
2024-05-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent (CHOICE)
NCT03413852
Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)
NCT04095819
Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)
NCT06163547
Chronic Subdural Hematoma Embolization With Detachable Coils
NCT07291427
Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study
NCT06347796
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Imaging assessment by blinded core laboratory
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SQUID
Embolization of the Middle Meningeal Artery (MMA)
SQUID Embolization
Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent
SQUID Embolization and Surgical Evacuation
Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent and the surgical evacuation of the sub-dural hematoma
No Embolization
Standard Management
Surgical Evacuation
Surgical evacuation of the sub-dural hematoma
Other: Medical Management
Standard
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SQUID Embolization
Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent
SQUID Embolization and Surgical Evacuation
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
Surgical evacuation of the sub-dural hematoma
Other: Medical Management
Standard
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Pre-morbid mRS 0-1 within the previous 12 months
3. cSDH measures ≥ 10 mm in greatest thickness
4. cSDH exerts mass effect upon the subjacent brain, as indicated by local cortical flattening or midline shift
5. 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))
6. 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
7. 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
8. 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
9. 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
Exclusion Criteria
2. Subject with prior Embolization of either MMA
3. Subject requires (in the opinion of the treating surgeon) a full or mini craniotomy
4. Subject with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed
5. Subject with a cSDH with a focal location (confined to the frontal or temporal base or the inter-hemispheric space without cerebral convexity involvement)
6. cSDH developed due to underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or secondary to a previous craniotomy
7. Life expectancy of \<1 year
8. Subject who presents with an intracranial mass other than subdural hematoma
9. 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
10. Subject with serum creatinine level \> 3.0 mg/dL at time of enrollment (this will restrict the use of contrast) and not on dialysis
11. Subject with significant liver function impairment at the time of enrollment
12. Subject with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically)
13. Subject who is currently enrolled in another investigational study protocol that could potentially confound the current study endpoints
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Balt USA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Fiorella, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University Medical Center
Adam Arthur, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Semmes-Murphy Neurologic and Spine Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Chu Cote de Nacre
Caen, , France
CHU Hopital Bicetre
Le Kremlin-Bicêtre, , 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, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIP-201912-SQUID
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.