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

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ClinicalTrials.gov Identifier: NCT04402632
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : February 7, 2024
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Tracking Information
First Submitted Date  ICMJE May 18, 2020
First Posted Date  ICMJE May 27, 2020
Last Update Posted Date February 7, 2024
Actual Study Start Date  ICMJE October 27, 2020
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2020)		 Effectiveness: Incidence of hematoma recurrence/progression requiring re-intervention [ Time Frame: 90 days post-procedure ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2020)		 Effectiveness: Incidence of hematoma recurrence/progression requiring re-intervention [ Time Frame: 60 days post-procedure ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2020)
  • Non-inferiority assessment of Onyx™ LES embolization treatment compared to standard of care based on change in Modified Rankin Scale Score [ Time Frame: 90 days post-procedure ]
  • Effectiveness: Incidence of hospital readmissions [ Time Frame: 90 days post-procedure ]
  • Effectiveness: Change in hematoma volume based on CT/MRI imaging [ Time Frame: 90 days post-procedure ]
  • Effectiveness: Change in hematoma thickness per CT/MRI imaging [ Time Frame: 90 days post-procedure ]
  • Effectiveness: Change in midline shift based on CT/MRI imaging [ Time Frame: 90 days post-procedure ]
  • Safety: Incidence of device-related serious adverse events [ Time Frame: 30 days post-procedure ]
  • Safety: Incidence of procedure-related serious adverse events [ Time Frame: 30 days post-procedure ]
  • Safety: Incidence of neurological death [ Time Frame: 90 days and 180 days post-procedure ]
  • Safety: Incidence of device-related adverse events [ Time Frame: 90 days and 180 days post-procedure ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2020)
  • Effectiveness: Rate of successful procedural embolization of the target vessel based on DSA imaging [ Time Frame: Day 0 ]
  • Effectiveness: Change in hematoma thickness based on CT/MRI imaging [ Time Frame: 60 days post-procedure ]
  • Effectiveness: Change in Midline shift based on CT/MRI imaging [ Time Frame: 60 days post-procedure ]
  • Effectiveness: Change in Markwalder scale Grade 0 (normal) to Grade 4 (comatose) [ Time Frame: 24 hours, 2 weeks, 60 days, and 180 days post-procedure ]
  • Effectiveness: Change in Motor strength scale Grade 0 (no movement) to Grade 5 (normal) [ Time Frame: 24 hours, 2 weeks, 60 days, and 180 days post-procedure ]
  • Effectiveness: Level of consciousness with Glasgow Coma Scale (GCS) from severe brain injury (0-8), moderate brain injury (9-12) and mild brain injury (13-15) [ Time Frame: 24 hours, 2 weeks, 60 days, and 180 days post-procedure ]
  • Effectiveness: Change in the Modified Rankin Scale score (mRS) Grade 0 (no symptoms) to 6 (death) [ Time Frame: 60 days and 180 days post-procedure ]
  • Effectiveness: Percentage of patients with favorable functional outcome defined as Modified Rankin Scale of 0 to 3 [ Time Frame: 60 days and 180 days post-procedure ]
  • Effectiveness: Percentage of patients with good functional outcome defined as Modified Rankin Scale of 0 to 2 [ Time Frame: 60 days and 180 days post-procedure ]
  • Effectiveness: Quality of life assessed by (EuroQol) EQ-5D scale Grade 0 (worst health) to 100 (best health) [ Time Frame: 60 days and 180 days post-procedure ]
  • Safety: Incidence of neurological death [ Time Frame: 60 days and 180 days post-procedure ]
  • Safety: Incidence of procedural serious complications [ Time Frame: 30 days post-procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma
Official Title  ICMJE 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)
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Subdural Hematoma
Intervention  ICMJE
  • Procedure: Surgical Management
    SDH Evacuation (Control)
  • Device: Surgical Management + Treatment
    SDH Evacuation + Onyx™ LES Embolization
  • Other: No Treatment
    Observation Only (Control)
  • Device: Treatment
    Onyx™ LES Embolization
Study Arms  ICMJE
  • Active Comparator: Surgery Cohort: Control Arm
    Control
    Intervention: Procedure: Surgical Management
  • Experimental: Surgery Cohort: Treatment Arm
    Treatment
    Intervention: Device: Surgical Management + Treatment
  • Active Comparator: Observational Cohort: Control Arm
    Control
    Intervention: Other: No Treatment
  • Experimental: Observational Cohort: Treatment Arm
    Treatment
    Intervention: Device: Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2020)		 600
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2020)		 525
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Medtronic Neurovascular Clinical Affairs 1(949) 837-3700 rs.embolisestudy@medtronic.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04402632
Other Study ID Numbers  ICMJE MDT19027ONYX
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No individual participant data will be available
Current Responsible Party Medtronic Neurovascular Clinical Affairs
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medtronic Neurovascular Clinical Affairs
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jared Knopman, MD New York-Presbyterian Hospital/Weill Cornell Medical Center
Principal Investigator: Jason Davies, MD Buffalo General Medical Center
PRS Account Medtronic Neurovascular Clinical Affairs
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP