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

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)

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)

Study Overview

• Status: Recruiting
• Conditions: Subdural Hematoma
• Intervention / Treatment: Procedure: Surgical Management; Device: Surgical Management + Treatment; Other: No Treatment; Device: Treatment

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Medtronic Neurovascular Clinical Affairs; Phone Number: 1(949) 837-3700; Email: rs.embolisestudy@medtronic.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1932
      • Recruiting
      • University of Alabama at Birmingham (UAB) Hospital
      • Contact: Jesse Jones, MD
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Recruiting
      • Carondelet St. Joseph's Hospital
      • Contact: Alexander Coon, MD
  • California
    • Irvine, California, United States, 92868
      • Recruiting
      • University of California Irvine Medical Center
      • Contact: Shuichi Suzuki, MD
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC - Keck School of Medicine
      • Contact: William Mack, MD
    • Pasadena, California, United States, 91105
      • Recruiting
      • Huntington Memorial Hospital
      • Contact: Ian Ross, MD
    • San Diego, California, United States, 92037
      • Recruiting
      • UCSD Medical Center
      • Contact: Jeffrey Pannell, MD
    • San Francisco, California, United States, 94109
      • Recruiting
      • California Pacific Medical Center
      • Contact: Fabio Settecase, MD
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco Medical Center
      • Contact: Steven Hetts, MD
    • Torrance, California, United States, 90503-4607
      • Recruiting
      • Providence Little Company of Mary Medical Center
      • Contact: Jason Tarpley, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Denver School of Medicine
      • Contact: Christopher Roark, MD
  • Florida
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • UF Health Heart and Vascular Hospital
      • Contact: Matthew Koch, MD
    • Hollywood, Florida, United States, 33021
      • Recruiting
      • Memorial Regional Hospital
      • Contact: Norman Ajiboye, MD
    • Jacksonville, Florida, United States, 322047
      • Recruiting
      • Baptist Medical Center Jacksonville
      • Contact: Ricardo Hanel, MD
    • Miami, Florida, United States, 33136
      • Recruiting
      • Jackson Memorial Hospital
      • Contact: Robert Starke, MD
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Regional Medical Center Orlando Health
      • Contact: Marshall Cress, MD
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
      • Contact: Maxim Mokin, MD
    • West Palm Beach, Florida, United States, 33407
      • Recruiting
      • Saint Mary's Medical Center
      • Contact: Ali Malek, MD
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Recruiting
      • Grady Memorial Hospital
      • Contact: Jonathan Grossberg, MD
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Richard Webster Crowley, MD
    • Park Ridge, Illinois, United States, 60068
      • Recruiting
      • Advocate Lutheran General Hospital
      • Contact: Joshua Billingsley, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Ascension Saint Vincent Hospital
      • Contact: Daniel Sahlein, MD
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Hospitals and Clinics
      • Contact: Kathleen Dlouhy, MD
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University of Kentucky Albert B Chandler Hospital
      • Contact: Justin Fraser, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Mohammad Aziz-Sultan, MD
    • Burlington, Massachusetts, United States, 01805-0001
      • Recruiting
      • Lahey Hospital & Medical Center
      • Contact: Neil Patel, MD
  • Michigan
    • Flint, Michigan, United States, 48532
      • Recruiting
      • McLaren Flint Hospital
      • Contact: Aniel Majjhoo, MD
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Spectrum Health Hospital
      • Contact: Justin Singer, MD
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Barnes-jewish Hospital
      • Contact: Joshua Osbun, MD
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical Center
      • Contact: Alexandra Paul, MD
    • Buffalo, New York, United States, 14203
      • Recruiting
      • Buffalo General Medical Center
      • Contact: Jason Davies, MD
    • Manhasset, New York, United States, 11030
      • Recruiting
      • North Shore University Hospital
      • Contact: Thomas Link, MD
    • New York, New York, United States, 10029
      • Active, not recruiting
      • The Mount Sinai Hospital
    • New York, New York, United States, 10065
      • Recruiting
      • New York-Presbyterian Hospital/Weill Cornell Medical Center
      • Contact: Jared Knopman, MD
    • Valhalla, New York, United States, 10595
      • Recruiting
      • Westchester Medical Center
      • Contact: Justin Santarelli, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Atrium Health's Carolinas Medical Center
      • Contact: Joe Bernard, MD
  • Ohio
    • Cleveland, Ohio, United States, 44195-0001
      • Recruiting
      • Cleveland Clinic
      • Contact: Mark Bain, MD
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University/Wexner Medical Center
      • Contact: Patrick Youssef, MD
    • Toledo, Ohio, United States, 43606
      • Recruiting
      • ProMedica Toledo Hospital
      • Contact: Mouhammad Jumaa, MD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Active, not recruiting
      • Oklahoma University Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239-3011
      • Recruiting
      • Oregon Health & Science University Hospital
      • Contact: Jesse Liu, MD
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Recruiting
      • Geisinger Medical Center
      • Contact: Clemens Schirmer, MD
    • Pittsburgh, Pennsylvania, United States, 15213-2536
      • Recruiting
      • University of Pittsburgh Medical Center UPMC Presbyterian
      • Contact: Bradley Gross, MD
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Prisma Health
      • Contact: Mohammad Chaudry, MD
  • Texas
    • Harlingen, Texas, United States, 78550
      • Active, not recruiting
      • Valley Baptist Medical Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann-Texas Medical Center
      • Contact: Peng Chen, MD
    • Temple, Texas, United States, 76508-0001
      • Recruiting
      • Baylor Scott & White Medical Center - Temple
      • Contact: Walter Lesley, MD
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah Hospital
      • Contact: Ramesh Grandhi, MD
  • Washington
    • Seattle, Washington, United States, 98104-2420
      • Recruiting
      • Harborview Medical Center
      • Contact: Michael Levitt, MD
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Recruiting
      • Aurora Saint Luke's Medical Center
      • Contact: Thomas Wolfe, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effectiveness: Incidence of hematoma recurrence/progression requiring re-intervention	90 days post-procedure

Secondary Outcome Measures

Outcome Measure	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

• 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

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Chronic Disease; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: MDT19027ONYX

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes