U.S. flag

An official website of the United States government

Skip to main page content
Active, not recruiting

Embolization of the Middle Meningeal Artery with ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma (EMBOLISE)

ClinicalTrials.gov ID NCT04402632
Sponsor Medtronic Neurovascular Clinical Affairs
Information provided by Medtronic Neurovascular Clinical Affairs (Responsible Party)
Last Update Posted 2025-01-24
Bookmark

Study Overview

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)
Official 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)
Conditions
Subdural Hematoma
Intervention / Treatment
  • Procedure: Surgical Management
  • Device: Surgical Management + Treatment
  • Other: No Treatment
  • Device: Treatment
  • Procedure: Surgical Management
  • Device: Surgical Management + Treatment
  • Other: No Treatment
  • Device: Treatment
Other Study ID Numbers
  • MDT19027ONYX
Study Start (Actual)
2020-10-27
Primary Completion (Actual)
2024-12-19
Study Completion (Estimated)
2025-03
Enrollment (Estimated)
600
Study Type
Interventional
Phase
Not Applicable

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 49 locations
United States
Alabama Locations
Birmingham, Alabama, United States, 35233-1932

University of Alabama at Birmingham (UAB) Hospital
Arizona Locations
Tucson, Arizona, United States, 85710

Carondelet St. Joseph's Hospital
California Locations
Irvine, California, United States, 92868

University of California Irvine Medical Center
Los Angeles, California, United States, 90033

USC - Keck School of Medicine
Pasadena, California, United States, 91105

Huntington Memorial Hospital
San Diego, California, United States, 92037

UCSD Medical Center
San Francisco, California, United States, 94109

California Pacific Medical Center
San Francisco, California, United States, 94143

University of California San Francisco Medical Center
Torrance, California, United States, 90503-4607

Providence Little Company of Mary Medical Center
Colorado Locations
Aurora, Colorado, United States, 80045

University of Colorado Denver School of Medicine
Florida Locations
Gainesville, Florida, United States, 32608

UF Health Heart and Vascular Hospital
Hollywood, Florida, United States, 33021

Memorial Regional Hospital
Jacksonville, Florida, United States, 322047

Baptist Medical Center Jacksonville
Miami, Florida, United States, 33136

Jackson Memorial Hospital
Orlando, Florida, United States, 32806

Orlando Regional Medical Center Orlando Health
Tampa, Florida, United States, 33606

Tampa General Hospital
West Palm Beach, Florida, United States, 33407

Saint Mary's Medical Center
Georgia Locations
Atlanta, Georgia, United States, 30303

Grady Memorial Hospital
Illinois Locations
Chicago, Illinois, United States, 60612

Rush University Medical Center
Park Ridge, Illinois, United States, 60068

Advocate Lutheran General Hospital
Indiana Locations
Indianapolis, Indiana, United States, 46260

Ascension Saint Vincent Hospital
Iowa Locations
Iowa City, Iowa, United States, 52242

University of Iowa Hospitals and Clinics
Kentucky Locations
Lexington, Kentucky, United States, 40506

University of Kentucky Albert B Chandler Hospital
Massachusetts Locations
Boston, Massachusetts, United States, 02115

Brigham and Women's Hospital
Burlington, Massachusetts, United States, 01805-0001

Lahey Hospital & Medical Center
Michigan Locations
Flint, Michigan, United States, 48532

McLaren Flint Hospital
Grand Rapids, Michigan, United States, 49503

Spectrum Health Hospital
Missouri Locations
Saint Louis, Missouri, United States, 63110

Barnes-Jewish Hospital
New York Locations
Albany, New York, United States, 12208

Albany Medical Center
Buffalo, New York, United States, 14203

Buffalo General Medical Center
Manhasset, New York, United States, 11030

North Shore University Hospital
New York, New York, United States, 10029

The Mount Sinai Hospital
New York, New York, United States, 10065

New York-Presbyterian Hospital/Weill Cornell Medical Center
Valhalla, New York, United States, 10595

Westchester Medical Center
North Carolina Locations
Charlotte, North Carolina, United States, 28204

Atrium Health's Carolinas Medical Center
Ohio Locations
Cleveland, Ohio, United States, 44195-0001

Cleveland Clinic
Columbus, Ohio, United States, 43210

The Ohio State University/Wexner Medical Center
Toledo, Ohio, United States, 43606

ProMedica Toledo Hospital
Oklahoma Locations
Oklahoma City, Oklahoma, United States, 73104

Oklahoma University Medical Center
Oregon Locations
Portland, Oregon, United States, 97239-3011

Oregon Health & Science University Hospital
Pennsylvania Locations
Danville, Pennsylvania, United States, 17822

Geisinger Medical Center
Pittsburgh, Pennsylvania, United States, 15213-2536

University of Pittsburgh Medical Center UPMC Presbyterian
South Carolina Locations
Greenville, South Carolina, United States, 29605

Prisma Health
Texas Locations
Harlingen, Texas, United States, 78550

Valley Baptist Medical Center
Houston, Texas, United States, 77030

Memorial Hermann-Texas Medical Center
Temple, Texas, United States, 76508-0001

Baylor Scott & White Medical Center - Temple
Utah Locations
Salt Lake City, Utah, United States, 84132

University of Utah Hospital
Washington Locations
Seattle, Washington, United States, 98104-2420

Harborview Medical Center
Wisconsin Locations
Milwaukee, Wisconsin, United States, 53215

Aurora Saint Luke's Medical Center
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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
Show less
Ages Eligible for Study
18 Years to 90 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

/
Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Sequential Assignment
Masking : Single (Outcomes Assessor)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Active Comparator: Surgery Cohort: Control Arm
Control
Intervention/Treatment Procedure: Surgical Management
  • SDH Evacuation (Control)

Participant Group/Arm Experimental: Surgery Cohort: Treatment Arm
Treatment
Intervention/Treatment Device: Surgical Management + Treatment
  • SDH Evacuation + Onyx™ LES Embolization

Participant Group/Arm Active Comparator: Observational Cohort: Control Arm
Control
Intervention/Treatment Other: No Treatment
  • Observation Only (Control)

Participant Group/Arm Experimental: Observational Cohort: Treatment Arm
Treatment
Intervention/Treatment Device: Treatment
  • Onyx™ LES Embolization

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Effectiveness: Incidence of hematoma recurrence/progression requiring re-intervention 90 days post-procedure
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
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
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
Safety: Incidence of device-related serious adverse events 30 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Medtronic Neurovascular Clinical Affairs
Investigators
  • Principal Investigator:Jared Knopman, MD,New York-Presbyterian Hospital/Weill Cornell Medical Center
  • Principal Investigator:Jason Davies, MD,Buffalo General Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2020-05-18
First Submitted that Met QC Criteria
2020-05-20
First Posted
2020-05-27
Study Record Updates
Last Update Submitted that met QC Criteria
2025-01-22
Last Update Posted (Estimated)
2025-01-24
Last Verified
2025-01

More Information

/

Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No individual participant data will be available