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

NCT04410146 | Completed DMC FDA Device

• 1 other identifier: CIP-201912-SQUID
• Study Type: interventional
• Target: 310
• Locations: 4 countries
• Sites: 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)

Conditions

Subdural Hematoma, Chronic

Keywords

Meningeal Arteries; Intracranial Subdural Hematoma

Outcome Measures

Primary Outcomes (3)

• Primary Effectiveness Endpoint

  Treatment failure is defined by the occurrence of residual or re-accumulation of the SDH (≥10 mm) on 180-day scan from intervention.

  On 180-day from intervention

• Primary Effectiveness Endpoint

  Treatment failure is defined by the occurrence of any of the following events: * Re-operation (after index procedure) or surgical rescue * Any new, major disabling stroke, myocardial infarction (MI) or death from any (neurological) cause

  Within 180-days of intervention

• Primary Safety Endpoint

  Major disabling stroke or any death

  Within 30-days from intervention

Secondary Outcomes (2)

• mRS (analyzed as shift)

  180-day from intervention

• Any investigational device/procedure-related AE/SAE

  Through 1-year visit

Other Outcomes (8)

• mRS (analyzed as shift)

  30-day and 1-year from intervention

• mRS ≤ 2 (binary)

  30-day, 180-days, and 1-year from intervention

• Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neuro-cognitive battery HVLT-R, COWAT, Animal Naming, Trail making tests

  Baseline, 30-day, 180-day, and 1-year from intervention

Study Arms (2)

SQUID

EXPERIMENTAL

Embolization of the Middle Meningeal Artery (MMA)

Device: SQUID Embolization; Device: SQUID Embolization and Surgical Evacuation

No Embolization

ACTIVE COMPARATOR

Standard Management

Procedure: Surgical Evacuation; Other: Other: Medical Management

Interventions

SQUID Embolization DEVICE

Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent

SQUID

SQUID Embolization and Surgical Evacuation DEVICE

Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent and the surgical evacuation of the sub-dural hematoma

SQUID

Surgical Evacuation PROCEDURE

Surgical evacuation of the sub-dural hematoma

No Embolization

Other: Medical Management OTHER

Standard

No Embolization

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Balt USA: lead

Study Sites (32)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Carondolet St. Joseph's

Tucson, Arizona, 85711, United States

Location

Riverside Community Hospital

Riverside, California, 92501, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

Los Robles Hospital and Medical Center

Thousand Oaks, California, 92360, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Baptist Health

Jacksonville, Florida, 32207, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

Location

Nebraska Health

Omaha, Nebraska, 68106, United States

Location

Overlook Medical Center

Summit, New Jersey, 07901, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Penn State Health Hershey Medical Center

Hershey, Pennsylvania, 17918, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Swedish Cherry Hill

Seattle, Washington, 98122, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Chu Cote de Nacre

Caen, 14000, France

Location

CHU Hopital Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Hopital Pitie Salpetriere

Paris, France

Location

CHU Hopital Maison Blanche

Reims, France

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Klinikum Nurnberg Sud

Nuremberg, Germany

Location

Gregorio Maranon Hospital

Madrid, 28007, Spain

Location

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: 39565980 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Hematoma, Subdural, Intracranial

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• David Fiorella, MD, PhD

  Stony Brook University Medical Center

  PRINCIPAL INVESTIGATOR

• Adam Arthur, MD, MPH

  Semmes-Murphy Neurologic and Spine Institute

  PRINCIPAL INVESTIGATOR

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: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); DE (2); FR (4); US (25)