Purpose

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)

Condition

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Surgery Cohort: Control Arm
Control
  • Procedure: Surgical Management
    SDH Evacuation (Control)
Experimental
Surgery Cohort: Treatment Arm
Treatment
  • Device: Surgical Management + Treatment
    SDH Evacuation + Onyx™ LES Embolization
Active Comparator
Observational Cohort: Control Arm
Control
  • Other: No Treatment
    Observation Only (Control)
Experimental
Observational Cohort: Treatment Arm
Treatment
  • Device: Treatment
    Onyx™ LES Embolization

Recruiting Locations

University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama 35233-1932

More Details

Status
Recruiting
Sponsor
Medtronic Neurovascular Clinical Affairs

Study Contact

Medtronic Neurovascular Clinical Affairs
1(949) 837-3700
rs.embolisestudy@medtronic.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.