Clinical trial NCT04402632: Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
Official title: A Study of the Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System In the Treatment of Subacute and Chronic Subdural HEmatoma (EMBOLISE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Subdural Hematoma
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2020-05-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)


Eligibility criteria: Inclusion Criteria:

* Pre-morbid Modified Rankin Score ≤3
* Confirmed diagnosis of subacute or chronic subdural hematoma
* Completed informed consent
* Meets criteria for Surgery or Observation Cohort

Exclusion Criteria:

* Life expectancy \<1 year
* Unable to complete follow-up
* Pregnant, lactating, or has a positive pregnancy test at time of admission
* Diagnosed with acute SDH
* Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization
* Pre-randomized Markwalder Grading Scale score ≥ 3
* Unmanaged, uncontrolled bleeding disorders/blood diathesis
* Presumed septic embolus, or suspicion of microbial superinfection
* Known active COVID-19 infection
* CT or MRI evidence of intra-cranial tumor or mass lesion Contraindication to angiography
* Participation in another clinical trial
* Contraindicated for the use of Onyx™ LES
* Cannot be taken off corticosteroids (intended to treat subacute or chronic SDH) for at least 90 days post-randomization

Primary outcomes:
measure: Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline
timeFrame: 90 days post-procedure
Secondary outcomes:
measure: Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score
timeFrame: 90 days post-procedure
measure: Effectiveness: Incidence of hospital readmissions
timeFrame: 90 days post-procedure
measure: Effectiveness: Change in hematoma volume based on CT/MRI imaging
timeFrame: 90 days post-procedure
measure: Effectiveness: Change in hematoma thickness per CT/MRI imaging
timeFrame: 90 days post-procedure
measure: Effectiveness: Change in midline shift based on CT/MRI imaging
timeFrame: 90 days post-procedure
measure: Safety: Incidence of device-related serious adverse events
timeFrame: 30 days post-procedure
measure: Safety: Incidence of procedure-related serious adverse events
timeFrame: 30 days post-procedure
measure: Safety: Incidence of neurological death
timeFrame: 90 days and 180 days post-procedure
measure: Safety: Incidence of device-related adverse events
timeFrame: 90 days and 180 days post-procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB) Hospital
state: Alabama
city: Tucson
country: United States
facility: Carondelet St. Joseph's Hospital
state: Arizona
city: Irvine
country: United States
facility: University of California Irvine Medical Center
state: California
city: Los Angeles
country: United States
facility: USC - Keck School of Medicine
state: California
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Torrance
country: United States
facility: Providence Little Company of Mary Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver School of Medicine
state: Colorado
city: Gainesville
country: United States
facility: UF Health Heart and Vascular Hospital
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center Jacksonville
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center Orlando Health
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: West Palm Beach
country: United States
facility: Saint Mary's Medical Center
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Ascension Saint Vincent Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Albert B Chandler Hospital
state: Kentucky
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Flint
country: United States
facility: McLaren Flint Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health's Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University/Wexner Medical Center
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University Hospital
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Presbyterian
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Harlingen
country: United States
facility: Valley Baptist Medical Center
state: Texas
city: Houston
country: United States
facility: Memorial Hermann-Texas Medical Center
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: New York-Presbyterian Hospital/Weill Cornell Medical Center
name: Jared Knopman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Buffalo General Medical Center
name: Jason Davies, MD
role: PRINCIPAL_INVESTIGATOR
References: