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

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)

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)

Study Overview

• Status: Completed
• Conditions: Subdural Hematoma
• Intervention / Treatment: Procedure: Surgical Management; Procedure: Surgical Management; Device: Onyx™ Liquid Embolic System (LES) Embolization; Other: Observation Only

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1932
      • University of Alabama at Birmingham (UAB) Hospital
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Carondelet St. Joseph's Hospital
  • California
    • Irvine, California, United States, 92868
      • University of California Irvine Medical Center
    • Los Angeles, California, United States, 90033
      • USC - Keck School of Medicine
    • Pasadena, California, United States, 91105
      • Huntington Memorial Hospital
    • San Diego, California, United States, 92037
      • UCSD Medical Center
    • San Francisco, California, United States, 94143
      • University of California San Francisco Medical Center
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center
    • Torrance, California, United States, 90503-4607
      • Providence Little Company of Mary Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver School of Medicine
  • Florida
    • Gainesville, Florida, United States, 32608
      • UF Health Heart and Vascular Hospital
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital
    • Jacksonville, Florida, United States, 322047
      • Baptist Medical Center Jacksonville
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center Orlando Health
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
    • West Palm Beach, Florida, United States, 33407
      • Saint Mary's Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Ascension Saint Vincent Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky Albert B Chandler Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Burlington, Massachusetts, United States, 01805-0001
      • Lahey Hospital & Medical Center
  • Michigan
    • Flint, Michigan, United States, 48532
      • McLaren Flint Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Buffalo, New York, United States, 14203
      • Buffalo General Medical Center
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital
    • New York, New York, United States, 10065
      • New York-Presbyterian Hospital/Weill Cornell Medical Center
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health's Carolinas Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195-0001
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University/Wexner Medical Center
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Medical center
  • Oregon
    • Portland, Oregon, United States, 97239-3011
      • Oregon Health & Science University Hospital
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213-2536
      • University of Pittsburgh Medical Center UPMC Presbyterian
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health
  • Texas
    • Harlingen, Texas, United States, 78550
      • Valley Baptist Medical Center
    • Houston, Texas, United States, 77030
      • Memorial Hermann-Texas Medical Center
    • Temple, Texas, United States, 76508-0001
      • Baylor Scott & White Medical Center - Temple
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital
  • Washington
    • Seattle, Washington, United States, 98104-2420
      • Harborview Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgery Cohort: Control Arm	Procedure: Surgical Management; Surgical Evacuation of the Subdural Hematoma (SDH) (Control); Procedure: Surgical Management; Surgical Evacuation of the Subdural Hematoma (SDH)
Experimental: Surgery Cohort: Treatment Arm	Procedure: Surgical Management; Surgical Evacuation of the Subdural Hematoma (SDH) (Control); Procedure: Surgical Management; Surgical Evacuation of the Subdural Hematoma (SDH); Device: Onyx™ Liquid Embolic System (LES) Embolization; Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Active Comparator: Observational Cohort: Control Arm	Other: Observation Only; Medical Management (Control)
Experimental: Observational Cohort: Treatment Arm	Device: Onyx™ Liquid Embolic System (LES) Embolization; Onyx™ LES Embolization of the Subdural Hematoma (SDH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline	90 days post-procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score	90 days post-procedure
Effectiveness: Incidence of hospital readmissions	90 days post-procedure
Effectiveness: Change in hematoma volume based on CT/MRI imaging	90 days post-procedure
Effectiveness: Change in hematoma thickness per CT/MRI imaging	90 days post-procedure
Effectiveness: Change in midline shift based on CT/MRI imaging	90 days post-procedure
Safety: Incidence of device-related serious adverse events	30 days post-procedure
Safety: Incidence of procedure-related serious adverse events	30 days post-procedure
Safety: Incidence of neurological death	90 days and 180 days post-procedure
Safety: Incidence of device-related adverse events	90 days and 180 days post-procedure

Collaborators and Investigators

• Sponsor: Medtronic Neurovascular Clinical Affairs
• Investigators: Principal Investigator: Jared Knopman, MD, New York-Presbyterian Hospital/Weill Cornell Medical Center; Principal Investigator: Jason Davies, MD, Buffalo General Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Actual): December 19, 2024
• Study Completion (Actual): April 3, 2025

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Pathological Conditions, Signs and Symptoms; Hematoma; Hematoma, Subdural; Therapeutics; Hemostatic Techniques; Therapeutic Occlusion; Embolization, Therapeutic
• Other Study ID Numbers: MDT19027ONYX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No