Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
NCT ID: NCT04402632
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
600 participants
INTERVENTIONAL
2020-10-27
2025-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Surgery Cohort: Control Arm
Surgical Management
Surgical Evacuation of the Subdural Hematoma (SDH) (Control)
Surgery Cohort: Treatment Arm
Onyx™ Liquid Embolic System (LES) Embolization
Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Surgical Management
Surgical Evacuation of the Subdural Hematoma (SDH)
Observational Cohort: Control Arm
Observation Only
Medical Management (Control)
Observational Cohort: Treatment Arm
Onyx™ Liquid Embolic System (LES) Embolization
Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Interventions
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Surgical Management
Surgical Evacuation of the Subdural Hematoma (SDH) (Control)
Onyx™ Liquid Embolic System (LES) Embolization
Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Observation Only
Medical Management (Control)
Onyx™ Liquid Embolic System (LES) Embolization
Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Surgical Management
Surgical Evacuation of the Subdural Hematoma (SDH)
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of subacute or chronic subdural hematoma
* Completed informed consent
* Meets criteria for Surgery or Observation Cohort
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Medtronic Neurovascular Clinical Affairs
INDUSTRY
Responsible Party
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Principal Investigators
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Jared Knopman, MD
Role: PRINCIPAL_INVESTIGATOR
New York-Presbyterian Hospital/Weill Cornell Medical Center
Jason Davies, MD
Role: PRINCIPAL_INVESTIGATOR
Buffalo General Medical Center
Locations
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University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States
Carondelet St. Joseph's Hospital
Tucson, Arizona, United States
University of California Irvine Medical Center
Irvine, California, United States
USC - Keck School of Medicine
Los Angeles, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
UCSD Medical Center
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
Providence Little Company of Mary Medical Center
Torrance, California, United States
University of Colorado Denver School of Medicine
Aurora, Colorado, United States
UF Health Heart and Vascular Hospital
Gainesville, Florida, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
Orlando Regional Medical Center Orlando Health
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Saint Mary's Medical Center
West Palm Beach, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Ascension Saint Vincent Hospital
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kentucky Albert B Chandler Hospital
Lexington, Kentucky, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
McLaren Flint Hospital
Flint, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Albany Medical Center
Albany, New York, United States
Buffalo General Medical Center
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
The Mount Sinai Hospital
New York, New York, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University/Wexner Medical Center
Columbus, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
Valley Baptist Medical Center
Harlingen, Texas, United States
Memorial Hermann-Texas Medical Center
Houston, Texas, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Harborview Medical Center
Seattle, Washington, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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Davies JM, Knopman J, Mokin M, Hassan AE, Harbaugh RE, Khalessi A, Fiehler J, Gross BA, Grandhi R, Tarpley J, Sivakumar W, Bain M, Crowley RW, Link TW, Fraser JF, Levitt MR, Chen PR, Hanel RA, Bernard JD, Jumaa M, Youssef P, Cress MC, Chaudry MI, Shakir HJ, Lesley WS, Billingsley J, Jones J, Koch MJ, Paul AR, Mack WJ, Osbun JW, Dlouhy K, Grossberg JA, Kellner CP, Sahlein DH, Santarelli J, Schirmer CM, Singer J, Liu JJ, Majjhoo AQ, Wolfe T, Patel NV, Roark C, Siddiqui AH; EMBOLISE Investigators. Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma. N Engl J Med. 2024 Nov 21;391(20):1890-1900. doi: 10.1056/NEJMoa2313472.
Other Identifiers
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MDT19027ONYX
Identifier Type: -
Identifier Source: org_study_id
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