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

Conditions

Subdural Hematoma

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)

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.

2026-01-01

10.1148/radiol.251746

Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma

Jason M. Davies, Jared Knopman, Maxim Mokin, Ameer E Hassan, Robert E. Harbaugh et al. (44 authors)

New England Journal of Medicine2024-11-20171 citations

10.1056/nejmoa2313472

Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)-protocol.

Zuo Q, Ni W, Yang P, Gu Y, Yu Y, Yang H, Majoie CBLM, Goyal M, Liu J, Mao Y, MAGIC-MT investigators.

2023-09-1413 citations

10.1186/s13063-023-07608-2

An artificial intelligence (AI)-based approach to clinical trial recruitment: The impact of Viz RECRUIT on enrollment in the EMBOLISE trial.

Hassan AE, Ravi S, Desai S, Saei HM, Mckennon E, Tekle WG.

2023-06-223 citations

10.1177/15910199231184604

Interventions

PROCEDURESurgical Management

Surgical Evacuation of the Subdural Hematoma (SDH) (Control)

DEVICEOnyx™ Liquid Embolic System (LES) Embolization

Onyx™ LES Embolization of the Subdural Hematoma (SDH)

OTHERObservation Only

Medical Management (Control)

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

No

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

Design outcomes

Primary

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

Measure	Time frame
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
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
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
Safety: Incidence of device-related serious adverse events	30 days post-procedure

Countries

United States

Outcome results

None listed