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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 2023

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).

Interventions

  • 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
  • Procedure: Surgical Evacuation
    • Surgical evacuation of the sub-dural hematoma
  • Other: Other: Medical Management
    • Standard

Arms, Groups and Cohorts

  • Experimental: SQUID
    • Embolization of the Middle Meningeal Artery (MMA)
  • Active Comparator: No Embolization
    • Standard Management

Clinical Trial Outcome Measures

Primary Measures

  • Primary Effectiveness Endpoint
    • Time Frame: On 180-day from intervention
    • Treatment failure is defined by the occurrence of residual or re-accumulation of the SDH (≥10 mm) on 180-day scan from intervention.
  • Primary Effectiveness Endpoint
    • Time Frame: Within 180-days of intervention
    • 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
  • Primary Safety Endpoint
    • Time Frame: Within 30-days from intervention
    • Major disabling stroke or any death

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Balt USA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Fiorella, MD, PhD, Principal Investigator, Stony Brook University Medical Center
    • Adam Arthur, MD, MPH, Principal Investigator, Semmes-Murphy Neurologic and Spine Institute

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