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Completed

NCT Number: NCT04402632

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

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)

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Key information

Conditions

Subdural Hematoma Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hematoma Hematoma, Subdural Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham (UAB) Hospital, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical management

Procedure

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

Onyx™ Liquid Embolic System (LES) Embolization

Device

Onyx™ LES Embolization of the Subdural Hematoma (SDH)

observation only

Other

Medical Management (Control)

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

    Time frame: 90 days post-procedure

Secondary outcomes

  1. 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

  2. Effectiveness: Incidence of hospital readmissions

    Time frame: 90 days post-procedure

  3. Effectiveness: Change in hematoma volume based on CT/MRI imaging

    Time frame: 90 days post-procedure

  4. Effectiveness: Change in hematoma thickness per CT/MRI imaging

    Time frame: 90 days post-procedure

  5. Effectiveness: Change in midline shift based on CT/MRI imaging

    Time frame: 90 days post-procedure

  6. Safety: Incidence of device-related serious adverse events

    Time frame: 30 days post-procedure

  7. Safety: Incidence of procedure-related serious adverse events

    Time frame: 30 days post-procedure

  8. Safety: Incidence of neurological death

    Time frame: 90 days and 180 days post-procedure

  9. Safety: Incidence of device-related adverse events

    Time frame: 90 days and 180 days post-procedure

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Official study 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)

Acronym: EMBOLISE

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
May 27, 2020
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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