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

Completed · Not applicable

Conditions studied: Subdural Hematoma

In brief

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)

Key facts

Study ID

NCT04402632

Run by

Medtronic Neurovascular Clinical Affairs

People needed

600

Starts

2020-10-27

Expected to finish

2025-04-03

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States
• Carondelet St. Joseph's Hospital — Tucson, Arizona, United States
• University of California Irvine Medical Center — Irvine, California, United States
• USC - Keck School of Medicine — Los Angeles, California, United States
• Huntington Memorial Hospital — Pasadena, California, United States
• UCSD Medical Center — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• Providence Little Company of Mary Medical Center — Torrance, California, United States
• University of Colorado Denver School of Medicine — Aurora, Colorado, United States
• UF Health Heart and Vascular Hospital — Gainesville, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Baptist Medical Center Jacksonville — Jacksonville, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• Orlando Regional Medical Center Orlando Health — Orlando, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Saint Mary's Medical Center — West Palm Beach, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States
• Ascension Saint Vincent Hospital — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kentucky Albert B Chandler Hospital — Lexington, Kentucky, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States

Full record on ClinicalTrials.gov

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