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

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)

Study Overview

• Status: Completed
• Conditions: Subdural Hematoma, Chronic
• Intervention / Treatment: Device: SQUID Embolization; Device: SQUID Embolization and Surgical Evacuation; Procedure: Surgical Evacuation; Other: Other: Medical Management

Detailed Description

The study objective is 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).

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • CHU Cote de Nacre
  • Le Kremlin-Bicêtre, France, 94275
    • CHU Hopital Bicetre
  • Paris, France
    • Hopital Pitie Salpetriere
  • Reims, France
    • CHU Hôpital Maison Blanche
• Germany
  • Heidelberg, Germany
    • UniversitatsKlinikum Heidelberg
  • Nurnberg, Germany
    • Klinikum Nürnberg Süd
• Spain
  • Madrid, Spain, 28007
    • Gregorio Marañon hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
    • Tucson, Arizona, United States, 85711
      • Carondolet St. Joseph's
  • California
    • Riverside, California, United States, 92501
      • Riverside Community Hospital
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
    • Thousand Oaks, California, United States, 92360
      • Los Robles Hospital and Medical Center
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Swedish Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Health
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Marietta, Georgia, United States, 30060
      • WellStar Kennestone Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68106
      • Nebraska Health
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Overlook Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10016
      • NYU Langone Health
    • Stony Brook, New York, United States, 11794
      • Stony Brook University
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Hershey, Pennsylvania, United States, 17918
      • Penn State Health Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
    • Memphis, Tennessee, United States, 38104
      • Methodist University Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Cherry Hill
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female Subject whose age is ≥ 30 at the time of consent
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:

1. Subject with prior ipsilateral craniotomy or burr hole evacuation of cSDH
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No Embolization; Standard Management	Procedure: Surgical Evacuation; Surgical evacuation of the sub-dural hematoma; Other: Other: Medical Management; Standard
Experimental: SQUID; Embolization of the Middle Meningeal Artery (MMA)	Device: SQUID Embolization; Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent; Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
mRS (analyzed as shift)	180-day from intervention
Any investigational device/procedure-related AE/SAE	Through 1-year visit

Other Outcome Measures

Outcome Measure	Time Frame
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
EQ-5D-5L (including EQ-VAS)	Baseline vs. 30-day, 180-day, and 1-year from intervention
Hospital Days	Through 1-year visit
Intensive Care Unit (ICU) Days	Through 1-year visit
NIHSS	Baseline vs Discharge and 90-day
CT/MRI	Baseline vs. 180 days

Collaborators and Investigators

• Sponsor: Balt USA
• Collaborators: AXIOM Real Time Metrics; Embo-Flüssigkeiten A.G.; Balt Extrusion
• Investigators: Principal Investigator: David Fiorella, MD, PhD, Stony Brook University Medical Center; Principal Investigator: Adam Arthur, MD, MPH, Semmes-Murphy Neurologic and Spine Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): May 23, 2024
• Study Completion (Actual): May 23, 2024

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Meningeal Arteries; Intracranial Subdural Hematoma
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
• Other Study ID Numbers: CIP-201912-SQUID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes