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)
1 other identifier
interventional
600
1 country
49
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedStudy Start
First participant enrolled
October 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2025
CompletedDecember 11, 2025
December 1, 2025
4.1 years
May 18, 2020
December 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (4)
Surgery Cohort: Control Arm
ACTIVE COMPARATORSurgery Cohort: Treatment Arm
EXPERIMENTALObservational Cohort: Control Arm
ACTIVE COMPARATORObservational Cohort: Treatment Arm
EXPERIMENTALInterventions
Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Surgical Evacuation of the Subdural Hematoma (SDH) (Control)
Eligibility Criteria
You may qualify if:
- Pre-morbid Modified Rankin Score ≤3
- Confirmed diagnosis of subacute or chronic subdural hematoma
- Completed informed consent
- Meets criteria for Surgery or Observation Cohort
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35233-1932, United States
Carondelet St. Joseph's Hospital
Tucson, Arizona, 85710, United States
University of California Irvine Medical Center
Irvine, California, 92868, United States
USC - Keck School of Medicine
Los Angeles, California, 90033, United States
Huntington Memorial Hospital
Pasadena, California, 91105, United States
UCSD Medical Center
San Diego, California, 92037, United States
California Pacific Medical Center
San Francisco, California, 94109, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
Providence Little Company of Mary Medical Center
Torrance, California, 90503-4607, United States
University of Colorado Denver School of Medicine
Aurora, Colorado, 80045, United States
UF Health Heart and Vascular Hospital
Gainesville, Florida, 32608, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, 322047, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Orlando Regional Medical Center Orlando Health
Orlando, Florida, 32806, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Saint Mary's Medical Center
West Palm Beach, Florida, 33407, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Ascension Saint Vincent Hospital
Indianapolis, Indiana, 46260, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky Albert B Chandler Hospital
Lexington, Kentucky, 40506, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805-0001, United States
McLaren Flint Hospital
Flint, Michigan, 48532, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Albany Medical Center
Albany, New York, 12208, United States
Buffalo General Medical Center
Buffalo, New York, 14203, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Cleveland Clinic
Cleveland, Ohio, 44195-0001, United States
The Ohio State University/Wexner Medical Center
Columbus, Ohio, 43210, United States
ProMedica Toledo Hospital
Toledo, Ohio, 43606, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health & Science University Hospital
Portland, Oregon, 97239-3011, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213-2536, United States
Prisma Health
Greenville, South Carolina, 29605, United States
Valley Baptist Medical Center
Harlingen, Texas, 78550, United States
Memorial Hermann-Texas Medical Center
Houston, Texas, 77030, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508-0001, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Harborview Medical Center
Seattle, Washington, 98104-2420, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Related Publications (2)
Kniep H, Gellissen S, Bechstein M, Meyer L, Broocks G, Heitkamp C, Winkelmeier L, Flottmann F, Geest V, Hanning U, Thaler C, Bester M, Davies JM, Knopman J, Mokin M, Hassan AE, Harbaugh RE, Khalessi A, Siddiqui AH, 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, Fiehler J; EMBOLISE Investigators. Middle Meningeal Artery Embolization for Subdural Hematoma: CT/MRI End Points of the EMBOLISE Trial. Radiology. 2026 Jan;318(1):e251746. doi: 10.1148/radiol.251746.
PMID: 41591252DERIVEDDavies 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.
PMID: 39565988DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jared Knopman, MD
New York-Presbyterian Hospital/Weill Cornell Medical Center
- PRINCIPAL INVESTIGATOR
Jason Davies, MD
Buffalo General Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 27, 2020
Study Start
October 27, 2020
Primary Completion
December 19, 2024
Study Completion
April 3, 2025
Last Updated
December 11, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
No individual participant data will be available