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

Exclusion Criteria

  • Life expectancy <1 year - Unable to complete follow-up - Pregnant, lactating, or has a positive pregnancy test at time of admission - Bilateral subacute or chronic SDH - Previous surgical interventions for subacute or chronic SDH - Unable to undergo MMA embolization prior to surgical treatment - Acute SDH - Potentially dangerous anatomic variations leading to increased procedural risk - Contraindicated for removal from anticoagulant medical therapy for at least 4 weeks post-randomization - Pre-randomized Markwalder Grading Scale score ≥ 3 - Unmanaged, uncontrolled bleeding disorders/blood diathesis - International normalized ratio [INR] ≤1.4 - Presumed septic embolus, or suspicion of microbial superinfection - 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 Onyx™ LES - Contraindicated for removal of corticosteroids 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
Interventional Cohort: Control Arm
Control
  • Procedure: Surgical Management
    SDH Evacuation (Control)
Experimental
Interventional Cohort: Treatment Arm
Treatment
  • Device: Surgical Management + Treatment
    SDH Evacuation + Embolization
Active Comparator
Observational Cohort: Control Arm
Control
  • Other: No Treatment
    Observation Only (Control)
Experimental
Observational Cohort: Treatment Arm
Treatment
  • Device: Treatment
    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.