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

Not Applicable

Completed

Conditions: Subdural Hematoma, Chronic

Interventions: Procedure: Surgical Evacuation
Device: SQUID Embolization
Device: SQUID Embolization and Surgical Evacuation

Registration Number: NCT04410146

Lead Sponsor: Balt USA

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)

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 310

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Embolization	Surgical Evacuation	Standard Management
SQUID	SQUID Embolization and Surgical Evacuation	Embolization of the Middle Meningeal Artery (MMA)
SQUID	SQUID Embolization	Embolization of the Middle Meningeal Artery (MMA)

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	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	Within 30-days from intervention	Major disabling stroke or any death

Secondary Outcome Measures

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

Trial Locations

Locations (32): Riverside Community Hospital
🇺🇸
Riverside, California, United States
Carondolet St. Joseph's
🇺🇸
Tucson, Arizona, United States
Santa Barbara Cottage Hospital
🇺🇸
Santa Barbara, California, United States
Los Robles Hospital and Medical Center
🇺🇸
Thousand Oaks, California, United States
Baptist Health
🇺🇸
Jacksonville, Florida, United States
University of Kansas
🇺🇸
Kansas City, Kansas, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Wellstar Kennestone Hospital
🇺🇸
Marietta, Georgia, 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
Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
Penn State Health Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States
Methodist University Hospital
🇺🇸
Memphis, Tennessee, United States
Baptist Memorial Hospital
🇺🇸
Memphis, Tennessee, 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
Klinikum Nurnberg Sud
🇩🇪
Nurnberg, Germany
Universitätsklinikum Heidelberg
🇩🇪
Heidelberg, Germany
Gregorio Maranon Hospital
🇪🇸
Madrid, Spain
Johns Hopkins Medicine
🇺🇸
Baltimore, Maryland, United States
Swedish Cherry Hill
🇺🇸
Seattle, Washington, United States
University of Utah
🇺🇸
Salt Lake City, Utah, United States
CHU Hopital Maison Blanche
🇫🇷
Reims, France
Swedish Medical Center
🇺🇸
Englewood, Colorado, United States
Barrow Neurological Institute
🇺🇸
Phoenix, Arizona, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States