Subdural HematomaEMBOLISENCT04402632
Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
A study testing Surgical Management, Onyx™ Liquid Embolic System (LES) Embolization and Observation Only in people with Subdural Hematoma, run by Medtronic Neurovascular Clinical Affairs at 49 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Subdural Hematoma
- What is being tested?
- Surgical Management, Onyx™ Liquid Embolic System (LES) Embolization and Observation Only
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 49 sitesUnited States
- Study dates
- 27 Oct 2020to 3 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-morbid Modified Rankin Score ≤3
- Confirmed diagnosis of subacute or chronic subdural hematoma
- Completed informed consent
- Meets criteria for Surgery or Observation Cohort
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
Albany Medical Center
Albany, New York, 12208
Grady Memorial Hospital
Atlanta, Georgia, 30303
University of Colorado Denver School of Medicine
Aurora, Colorado, 80045
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35233-1932
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Buffalo General Medical Center
Buffalo, New York, 14203
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805-0001
Atrium Health's Carolinas Medical Center
Charlotte, North Carolina, 28204
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195-0001
The Ohio State University/Wexner Medical Center
Columbus, Ohio, 43210
Geisinger Medical Center
Danville, Pennsylvania, 17822
McLaren Flint Hospital
Flint, Michigan, 48532
UF Health Heart and Vascular Hospital
Gainesville, Florida, 32608
Corewell Health
Grand Rapids, Michigan, 49503
Prisma Health
Greenville, South Carolina, 29605
Valley Baptist Medical Center
Harlingen, Texas, 78550
Memorial Regional Hospital
Hollywood, Florida, 33021
Memorial Hermann-Texas Medical Center
Houston, Texas, 77030
Ascension Saint Vincent Hospital
Indianapolis, Indiana, 46260
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of California Irvine Medical Center
Irvine, California, 92868
Baptist Medical Center Jacksonville
Jacksonville, Florida, 322047
University of Kentucky Albert B Chandler Hospital
Lexington, Kentucky, 40506
USC - Keck School of Medicine
Los Angeles, California, 90033
North Shore University Hospital
Manhasset, New York, 11030
Jackson Memorial Hospital
Miami, Florida, 33136
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215
The Mount Sinai Hospital
New York, New York, 10029
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
Orlando Regional Medical Center Orlando Health
Orlando, Florida, 32806
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Huntington Memorial Hospital
Pasadena, California, 91105
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213-2536
Oregon Health & Science University Hospital
Portland, Oregon, 97239-3011
University of Utah Hospital
Salt Lake City, Utah, 84132
UCSD Medical Center
San Diego, California, 92037
California Pacific Medical Center
San Francisco, California, 94109
University of California San Francisco Medical Center
San Francisco, California, 94143
Harborview Medical Center
Seattle, Washington, 98104-2420
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508-0001
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Providence Little Company of Mary Medical Center
Torrance, California, 90503-4607
Carondelet St. Joseph's Hospital
Tucson, Arizona, 85710
Westchester Medical Center
Valhalla, New York, 10595
Saint Mary's Medical Center
West Palm Beach, Florida, 33407
About this study
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)
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)
- Conditions
- Subdural Hematoma
- Being tested
- Surgical Management, Onyx™ Liquid Embolic System (LES) Embolization, Observation Only
- Medical subject headings
- Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical ManagementProcedure or surgery
Surgical Evacuation of the Subdural Hematoma (SDH) (Control)
Onyx™ Liquid Embolic System (LES) EmbolizationDevice
Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Observation OnlyOther
Medical Management (Control)
Onyx™ Liquid Embolic System (LES) EmbolizationDevice
Onyx™ LES Embolization of the Subdural Hematoma (SDH)
Surgical ManagementProcedure or surgery
Surgical Evacuation of the Subdural Hematoma (SDH)
| Study group | Role | What they receive |
|---|---|---|
| Surgery Cohort: Control Arm | Active comparator | Not described Receives: Procedure: Surgical Management |
| Surgery Cohort: Treatment Arm | Experimental | Not described Receives: Device: Onyx™ Liquid Embolic System (LES) Embolization; Procedure: Surgical Management |
| Observational Cohort: Control Arm | Active comparator | Not described Receives: Other: Observation Only |
| Observational Cohort: Treatment Arm | Experimental | Not described Receives: Device: Onyx™ Liquid Embolic System (LES) Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline
Measured: 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
Measured: 90 days post-procedure
Effectiveness: Incidence of hospital readmissions
Measured: 90 days post-procedure
Effectiveness: Change in hematoma volume based on CT/MRI imaging
Measured: 90 days post-procedure
Effectiveness: Change in hematoma thickness per CT/MRI imaging
Measured: 90 days post-procedure
Effectiveness: Change in midline shift based on CT/MRI imaging
Measured: 90 days post-procedure
Safety: Incidence of device-related serious adverse events
Measured: 30 days post-procedure
Safety: Incidence of procedure-related serious adverse events
Measured: 30 days post-procedure
Safety: Incidence of neurological death
Measured: 90 days and 180 days post-procedure
Safety: Incidence of device-related adverse events
Measured: 90 days and 180 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start27 Oct 2020
- Primary completion19 Dec 2024
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jared Knopman, MD, Principal investigator, New York-Presbyterian Hospital/Weill Cornell Medical CenterJason Davies, MD, Principal investigator, Buffalo General Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402632
- Sponsor's protocol ID
- MDT19027ONYX
- Acronym
- EMBOLISE
- Status last verified
- Dec 2025
- First submitted
- 18 May 2020
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No individual participant data will be available
Publications
Mokin M, Knopman J, Davies JM, Hassan AE, Harbaugh RE, Khalessi A, Fiehler J, Levy EI, 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, Mazaris P, Liu JJ, Majjhoo AQ, Wolfe T, Patel NV, Roark C, Siddiqui AH. Timing of Middle Meningeal Artery Embolization and Surgery: Analysis of the EMBOLISE Trial. Stroke Vasc Interv Neurol. 2026 Aug 13;6(5):e002359. doi: 10.1161/SVIN.126.002359. eCollection 2026 Sep.
PubMed 42708118Kniep 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.
PubMed 41591252Davies 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.
PubMed 39565988
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04402632
- Acronym / sponsor ID
- EMBOLISE / MDT19027ONYX
- Conditions
- Subdural Hematoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Surgery Cohort: Control Arm | Active comparator | Procedure: Surgical Management |
| Surgery Cohort: Treatment Arm | Experimental | Device: Onyx™ Liquid Embolic System (LES) Embolization, Procedure: Surgical Management |
| Observational Cohort: Control Arm | Active comparator | Other: Observation Only |
| Observational Cohort: Treatment Arm | Experimental | Device: Onyx™ Liquid Embolic System (LES) Embolization |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pre-morbid Modified Rankin Score ≤3
- Confirmed diagnosis of subacute or chronic subdural hematoma
- Completed informed consent
- Meets criteria for Surgery or Observation Cohort
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical ManagementSurgical Evacuation of the Subdural Hematoma (SDH) (Control) | Procedure or surgery | Surgery Cohort: Control Arm |
| Onyx™ Liquid Embolic System (LES) EmbolizationOnyx™ LES Embolization of the Subdural Hematoma (SDH) | Device | Surgery Cohort: Treatment Arm |
| Observation OnlyMedical Management (Control) | Other | Observational Cohort: Control Arm |
| Onyx™ Liquid Embolic System (LES) EmbolizationOnyx™ LES Embolization of the Subdural Hematoma (SDH) | Device | Observational Cohort: Treatment Arm |
| Surgical ManagementSurgical Evacuation of the Subdural Hematoma (SDH) | Procedure or surgery | Surgery Cohort: Treatment Arm |
Primary outcome
Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline
Time frame: 90 days post-procedure
9 secondary outcomes
Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score
Time frame: 90 days post-procedure
Effectiveness: Incidence of hospital readmissions
Time frame: 90 days post-procedure
Effectiveness: Change in hematoma volume based on CT/MRI imaging
Time frame: 90 days post-procedure
Effectiveness: Change in hematoma thickness per CT/MRI imaging
Time frame: 90 days post-procedure
Effectiveness: Change in midline shift based on CT/MRI imaging
Time frame: 90 days post-procedure
Safety: Incidence of device-related serious adverse events
Time frame: 30 days post-procedure
Safety: Incidence of procedure-related serious adverse events
Time frame: 30 days post-procedure
Safety: Incidence of neurological death
Time frame: 90 days and 180 days post-procedure
Safety: Incidence of device-related adverse events
Time frame: 90 days and 180 days post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Derived from this study: PubMed 42708118Mokin M, Knopman J, Davies JM, Hassan AE, Harbaugh RE, Khalessi A, Fiehler J, Levy EI, 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, Mazaris P, Liu JJ, Majjhoo AQ, Wolfe T, Patel NV, Roark C, Siddiqui AH. Timing of Middle Meningeal Artery Embolization and Surgery: Analysis of the EMBOLISE Trial. Stroke Vasc Interv Neurol. 2026 Aug 13;6(5):e002359. doi: 10.1161/SVIN.126.002359. eCollection 2026 Sep.
- Derived from this study: PubMed 41591252Kniep 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.
- Derived from this study: PubMed 39565988Davies 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.
- Individual participant dataSharing planned: No. No individual participant data will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Knopman, MD principal investigator
New York-Presbyterian Hospital/Weill Cornell Medical Center
Jason Davies, MD principal investigator
Buffalo General Medical Center
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Management, Onyx™ Liquid Embolic System (LES) Embolization and Observation Only in people with Subdural Hematoma, run by Medtronic Neurovascular Clinical Affairs at 49 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 90 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402632, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.