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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410146
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : November 10, 2022
Sponsor:
Collaborators:
Balt Extrusion
Embo-Flüssigkeiten A.G.
AXIOM Real Time Metrics
Information provided by (Responsible Party):
Balt USA

Study Description
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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)

Condition or disease Intervention/treatment Phase
Subdural Hematoma, Chronic Device: SQUID Procedure: Burr-hole Other: Medical Management Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:

Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neurocognitive battery.

Imaging assessment by Imaging blinded Core laboratory
Primary Purpose: Treatment
Official Title: The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Embolization
Middle Meningeal Artery (MMA) embolization
 Device: SQUID
Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent

Procedure: Burr-hole
Surgical evacuation of the sub-dural hematoma
Other Name: Twist-drill drainage

Other: Medical Management
Standard medical management: drug treatment and/or observation
Active Comparator: No Embolization
Standard Management
 Procedure: Burr-hole
Surgical evacuation of the sub-dural hematoma
Other Name: Twist-drill drainage

Other: Medical Management
Standard medical management: drug treatment and/or observation


Outcome Measures
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Primary Outcome Measures :
  1. Treatment failure [ Time Frame: within 180-days of intervention ]
    • Residual or re-accumulation of the SDH (≥10 mm) or
    • Re-operation (after index procedure) or surgical rescue or
    • Any new, major disabling stroke after enrollment, myocardial infarction (MI) or death from any (neurological) cause


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

10. 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 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
  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 participating in another clinical research study
  14. Subject who is unable to complete the required follow-up
  15. Female Subject who is pregnant and/or breastfeeding
  16. Subject who is currently enrolled in another investigational study protocol that could potentially confound the current study endpoints
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410146


Contacts
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Contact: Richelle Massey 510-493-1854 richelle.massey@baltgroup.com
Contact: Amanda Johnson amanda.johnson@baltgroup.com

Locations
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Sponsors and Collaborators
Balt USA
Balt Extrusion
Embo-Flüssigkeiten A.G.
AXIOM Real Time Metrics
Investigators
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Principal Investigator: David Fiorella, MD, PhD Stony Brook University Medical Center
Principal Investigator: Adam Arthur, MD, MPH Semmes-Murphy Neurologic and Spine Institute
More Information
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Responsible Party: Balt USA
ClinicalTrials.gov Identifier: NCT04410146    
Other Study ID Numbers: CIP-201912-SQUID
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Balt USA:
Meningeal Arteries
Intracranial Subdural Hematoma
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
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
Wounds and Injuries
Chronic Disease
Disease Attributes