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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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)

Condition or disease Intervention/treatment Phase
Subdural Hematoma Procedure: Surgical Management Device: Surgical Management + Treatment Other: No Treatment Device: Treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : August 2024

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness: Incidence of hematoma recurrence/progression requiring re-intervention [ Time Frame: 90 days post-procedure ]

Secondary Outcome Measures :
  1. 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 ]
  2. Effectiveness: Incidence of hospital readmissions [ Time Frame: 90 days post-procedure ]
  3. Effectiveness: Change in hematoma volume based on CT/MRI imaging [ Time Frame: 90 days post-procedure ]
  4. Effectiveness: Change in hematoma thickness per CT/MRI imaging [ Time Frame: 90 days post-procedure ]
  5. Effectiveness: Change in midline shift based on CT/MRI imaging [ Time Frame: 90 days post-procedure ]
  6. Safety: Incidence of device-related serious adverse events [ Time Frame: 30 days post-procedure ]
  7. Safety: Incidence of procedure-related serious adverse events [ Time Frame: 30 days post-procedure ]
  8. Safety: Incidence of neurological death [ Time Frame: 90 days and 180 days post-procedure ]
  9. Safety: Incidence of device-related adverse events [ Time Frame: 90 days and 180 days post-procedure ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402632


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

Locations
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Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
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Principal Investigator: Jared Knopman, MD New York-Presbyterian Hospital/Weill Cornell Medical Center
Principal Investigator: Jason Davies, MD Buffalo General Medical Center
More Information
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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT04402632    
Other Study ID Numbers: MDT19027ONYX
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: February 7, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Chronic Disease
Disease Attributes