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The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyxâ„¢ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery Cohort: Control Arm | Active Comparator |
| |
| Surgery Cohort: Treatment Arm | Experimental |
| |
| Observational Cohort: Control Arm | Active Comparator |
| |
| Observational Cohort: Treatment Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Management | Procedure | Surgical Evacuation of the Subdural Hematoma (SDH) (Control) |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority assessment of Onyxâ„¢ 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared Knopman, MD | New York-Presbyterian Hospital/Weill Cornell Medical Center | Principal Investigator |
| Jason Davies, MD | Buffalo General Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) Hospital | Birmingham | Alabama | 35233-1932 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41591252 | Derived | 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. | |
| 39565988 |
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No individual participant data will be available
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| Onyxâ„¢ Liquid Embolic System (LES) Embolization | Device | Onyxâ„¢ LES Embolization of the Subdural Hematoma (SDH) |
|
| Observation Only | Other | Medical Management (Control) |
|
| Onyxâ„¢ Liquid Embolic System (LES) Embolization | Device | Onyxâ„¢ LES Embolization of the Subdural Hematoma (SDH) |
|
| Surgical Management | Procedure | Surgical Evacuation of the Subdural Hematoma (SDH) |
|
| 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 |
| 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 |
| Derived |
| 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 7, 2026 | Jan 22, 2026 | 45 | ||
| Feb 12, 2026 | Mar 4, 2026 | 46 | ||
| Apr 1, 2026 | Apr 21, 2026 | 47 |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| ID | Term |
|---|---|
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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