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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 : November 26, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

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

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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 : January 2023
Estimated Study Completion Date : April 2023

Arm Intervention/treatment
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




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 ]


Information from the National Library of Medicine

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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-randomization Modified Rankin Score ≤3
  • Confirmed diagnosis of chronic or subacute 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
  • Previous coronary stent procedure(s) or heart valve surgery within the past 12 months
  • Contraindicated for removal from antiplatelet and/or anticoagulant medical therapy for at least 90 days post-randomization
  • Pre-randomized Markwalder Grading Scale score ≥ 3
  • CHADS2 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

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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United States, Colorado
University of Colorado Denver School of Medicine Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
United States, Kentucky
University of Kentucky Albert B Chandler Hospital Recruiting
Lexington, Kentucky, United States, 40506
United States, Missouri
Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Buffalo General Medical Center Recruiting
Buffalo, New York, United States, 14203
New York-Presbyterian Hospital/Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
United States, Ohio
The Ohio State University/Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
ProMedica Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
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
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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: November 26, 2020
Last Verified: November 2020
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