Clinical trial NCT04410146: The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
Official title: The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subdural Hematoma, Chronic
Keywords: Meningeal Arteries
Intracranial Subdural Hematoma
Lead sponsor: Balt USA
Sponsor class: INDUSTRY
First posted: 2020-06-01
Enrollment: 310
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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
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

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: On 180-day from intervention
measure: Primary Effectiveness Endpoint
timeFrame: Within 180-days of intervention
measure: Primary Safety Endpoint
timeFrame: Within 30-days from intervention
Secondary outcomes:
measure: mRS (analyzed as shift)
timeFrame: 180-day from intervention
measure: Any investigational device/procedure-related AE/SAE
timeFrame: Through 1-year visit
Other outcomes:
measure: mRS (analyzed as shift)
timeFrame: 30-day and 1-year from intervention
measure: mRS ≤ 2 (binary)
timeFrame: 30-day, 180-days, and 1-year from intervention
measure: Cognitive improvement, as measured by blinded assessment, utilizing the comprehensive neuro-cognitive battery HVLT-R, COWAT, Animal Naming, Trail making tests
timeFrame: Baseline, 30-day, 180-day, and 1-year from intervention
measure: EQ-5D-5L (including EQ-VAS)
timeFrame: Baseline vs. 30-day, 180-day, and 1-year from intervention
measure: Hospital Days
timeFrame: Through 1-year visit
measure: Intensive Care Unit (ICU) Days
timeFrame: Through 1-year visit
measure: NIHSS
timeFrame: Baseline vs Discharge and 90-day
measure: CT/MRI
timeFrame: Baseline vs. 180 days
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Tucson
country: United States
facility: Carondolet St. Joseph's
state: Arizona
city: Riverside
country: United States
facility: Riverside Community Hospital
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hospital and Medical Center
state: California
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: Jacksonville
country: United States
facility: Baptist Health
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Marietta
country: United States
facility: Wellstar Kennestone Hospital
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
city: Omaha
country: United States
facility: Nebraska Health
state: Nebraska
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: Swedish Cherry Hill
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Caen
country: France
facility: Chu Cote de Nacre
city: Le Kremlin-Bicêtre
country: France
facility: CHU Hopital Bicetre
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Reims
country: France
facility: CHU Hopital Maison Blanche
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Nurnberg
country: Germany
facility: Klinikum Nurnberg Sud
city: Madrid
country: Spain
facility: Gregorio Maranon Hospital
Study officials:
affiliation: Stony Brook University Medical Center
name: David Fiorella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Semmes-Murphy Neurologic and Spine Institute
name: Adam Arthur, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: