Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma

Last updated: June 23, 2025
Sponsor: Medtronic Neurovascular Clinical Affairs
Overall Status: Completed

Phase

N/A

Condition

Brain Injury

Treatment

Surgical Management + Treatment

Surgical Management

Treatment

Clinical Study ID

NCT04402632
MDT19027ONYX
  • Ages 18-90
  • All Genders

Study 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

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

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 orunsafe 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 toangiography

  • Participation in another clinical trial

  • Contraindicated for the use of Onyx™ LES

  • Cannot be taken off corticosteroids (intended to treat subacute or chronic SDH) forat least 90 days post-randomization

Study Design

Total Participants: 600
Treatment Group(s): 4
Primary Treatment: Surgical Management + Treatment
Phase:
Study Start date:
October 27, 2020
Estimated Completion Date:
April 03, 2025

Connect with a study center

  • University of Alabama at Birmingham (UAB) Hospital

    Birmingham, Alabama 35233-1932
    United States

    Site Not Available

  • Carondelet St. Joseph's Hospital

    Tucson, Arizona 85710
    United States

    Site Not Available

  • University of California Irvine Medical Center

    Irvine, California 92868
    United States

    Site Not Available

  • USC - Keck School of Medicine

    Los Angeles, California 90033
    United States

    Site Not Available

  • Huntington Memorial Hospital

    Pasadena, California 91105
    United States

    Site Not Available

  • UCSD Medical Center

    San Diego, California 92037
    United States

    Site Not Available

  • California Pacific Medical Center

    San Francisco, California 94109
    United States

    Site Not Available

  • University of California San Francisco Medical Center

    San Francisco, California 94143
    United States

    Site Not Available

  • Providence Little Company of Mary Medical Center

    Torrance, California 90503-4607
    United States

    Site Not Available

  • University of Colorado Denver School of Medicine

    Aurora, Colorado 80045
    United States

    Site Not Available

  • UF Health Heart and Vascular Hospital

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Memorial Regional Hospital

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida 322047
    United States

    Site Not Available

  • Jackson Memorial Hospital

    Miami, Florida 33136
    United States

    Site Not Available

  • Orlando Regional Medical Center Orlando Health

    Orlando, Florida 32806
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Saint Mary's Medical Center

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Grady Memorial Hospital

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Ascension Saint Vincent Hospital

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kentucky Albert B Chandler Hospital

    Lexington, Kentucky 40506
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts 01805-0001
    United States

    Site Not Available

  • McLaren Flint Hospital

    Flint, Michigan 48532
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Spectrum Health Hospital

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • Buffalo General Medical Center

    Buffalo, New York 14203
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York 10065
    United States

    Site Not Available

  • The Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Westchester Medical Center

    Valhalla, New York 10595
    United States

    Site Not Available

  • Atrium Health's Carolinas Medical Center

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195-0001
    United States

    Site Not Available

  • The Ohio State University/Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • ProMedica Toledo Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Oregon Health & Science University Hospital

    Portland, Oregon 97239-3011
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • University of Pittsburgh Medical Center UPMC Presbyterian

    Pittsburgh, Pennsylvania 15213-2536
    United States

    Site Not Available

  • Prisma Health

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Valley Baptist Medical Center

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Memorial Hermann-Texas Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Baylor Scott & White Medical Center - Temple

    Temple, Texas 76508-0001
    United States

    Site Not Available

  • University of Utah Hospital

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Harborview Medical Center

    Seattle, Washington 98104-2420
    United States

    Site Not Available

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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