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

Sponsor
Medtronic Neurovascular Clinical Affairs (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04402632
Collaborator
(none)
600
Enrollment
36
Locations
4
Arms
45.1
Anticipated Duration (Months)
16.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Surgical Management
  • Device: Surgical Management + Treatment
  • Other: No Treatment
  • Device: Treatment
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 27, 2020
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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

Primary Outcome Measures

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

  2. Effectiveness: Incidence of hospital readmissions [90 days post-procedure]

  3. Effectiveness: Change in hematoma volume based on CT/MRI imaging [90 days post-procedure]

  4. Effectiveness: Change in hematoma thickness per CT/MRI imaging [90 days post-procedure]

  5. Effectiveness: Change in midline shift based on CT/MRI imaging [90 days post-procedure]

  6. Safety: Incidence of device-related serious adverse events [30 days post-procedure]

  7. Safety: Incidence of procedure-related serious adverse events [30 days post-procedure]

  8. Safety: Incidence of neurological death [90 days and 180 days post-procedure]

  9. Safety: Incidence of device-related adverse events [90 days and 180 days post-procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham (UAB) Hospital Birmingham Alabama United States 35233-1932
2 USC - Keck School of Medicine Los Angeles California United States 90033
3 Huntington Memorial Hospital Pasadena California United States 91105
4 UCSD Medical Center San Diego California United States 92037
5 Providence Little Company of Mary Medical Center Torrance California United States 90503-4607
6 University of Colorado Denver School of Medicine Aurora Colorado United States 80045
7 UF Health Heart and Vascular Hospital Gainesville Florida United States 32608
8 Baptist Medical Center Jacksonville Jacksonville Florida United States 322047
9 Orlando Regional Medical Center Orlando Health Orlando Florida United States 32806
10 Tampa General Hospital Tampa Florida United States 33606
11 Rush University Medical Center Chicago Illinois United States 60612
12 Advocate Lutheran General Hospital Park Ridge Illinois United States 60068
13 Ascension Saint Vincent Hospital Indianapolis Indiana United States 46260
14 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
15 University of Kentucky Albert B Chandler Hospital Lexington Kentucky United States 40506
16 Lahey Hospital & Medical Center Burlington Massachusetts United States 01805-0001
17 McLaren Flint Hospital Flint Michigan United States 48532
18 Spectrum Health Hospital Grand Rapids Michigan United States 49503
19 Barnes-Jewish Hospital Saint Louis Missouri United States 63110
20 Buffalo General Medical Center Buffalo New York United States 14203
21 North Shore University Hospital Manhasset New York United States 11030
22 The Mount Sinai Hospital New York New York United States 10029
23 New York-Presbyterian Hospital/Weill Cornell Medical Center New York New York United States 10065
24 Westchester Medical Center Valhalla New York United States 10595
25 Atrium Health's Carolinas Medical Center Charlotte North Carolina United States 28204
26 Cleveland Clinic Cleveland Ohio United States 44195-0001
27 The Ohio State University/Wexner Medical Center Columbus Ohio United States 43210
28 ProMedica Toledo Hospital Toledo Ohio United States 43606
29 Oklahoma University Medical Center Oklahoma City Oklahoma United States 73104
30 Oregon Health & Science University Hospital Portland Oregon United States 97239-3011
31 University of Pittsburgh Medical Center UPMC Presbyterian Pittsburgh Pennsylvania United States 15213-2536
32 Valley Baptist Medical Center Harlingen Texas United States 78550
33 Baylor Scott & White Medical Center - Temple Temple Texas United States 76508-0001
34 University of Utah Hospital Salt Lake City Utah United States 84132
35 Harborview Medical Center Seattle Washington United States 98104-2420
36 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier:
NCT04402632
Other Study ID Numbers:
  • MDT19027ONYX
First Posted:
May 27, 2020
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma

Study Results

No Results Posted as of Aug 22, 2022