History of Changes for Study: NCT04402632

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

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Study Record Versions

Version	Submitted Date	Changes
1	May 20, 2020	None (earliest Version on record)
2	August 27, 2020	Study Status, Outcome Measures, Eligibility, Study Design and Study Description
3	September 25, 2020	Recruitment Status, Study Status and Contacts/Locations
4	October 9, 2020	Study Status
5	November 3, 2020	Study Status and Contacts/Locations
6	November 24, 2020	Study Design, Contacts/Locations and Study Status
7	February 1, 2021	Study Status and Eligibility
8	March 2, 2021	Study Status and Contacts/Locations
9	April 9, 2021	Study Status and Eligibility
10	May 20, 2021	Study Status and Contacts/Locations
11	July 9, 2021	Study Status and Contacts/Locations
12	September 3, 2021	Study Status and Contacts/Locations
13	September 7, 2021	Contacts/Locations and Study Status
14	November 1, 2021	Study Status and Contacts/Locations
15	December 8, 2021	Study Status and Contacts/Locations
16	December 16, 2021	Contacts/Locations and Study Status
17	February 2, 2022	Arms and Interventions, Study Status and Eligibility
18	March 11, 2022	Study Status and Contacts/Locations
19	May 16, 2022	Study Status and Contacts/Locations
20	June 10, 2022	Study Status and Contacts/Locations
21	July 14, 2022	Study Status and Contacts/Locations
22	July 29, 2022	Contacts/Locations and Study Status
23	August 18, 2022	Study Status and Contacts/Locations
24	September 30, 2022	Study Status and Contacts/Locations
25	March 16, 2023	Contacts/Locations and Study Status
26	June 7, 2023	Contacts/Locations and Study Status
27	July 20, 2023	Study Status and Contacts/Locations
28	September 19, 2023	Contacts/Locations and Study Status
29	October 3, 2023	Contacts/Locations and Study Status
30	October 5, 2023	Contacts/Locations and Study Status
31	October 17, 2023	Contacts/Locations and Study Status
32	November 2, 2023	Contacts/Locations and Study Status
33	January 25, 2024	Study Status and Contacts/Locations
34	February 6, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	MDT19027ONYX
Brief Title:	Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma (EMBOLISE)
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)
Secondary IDs:

Study Status


Record Verification:	June 2022
Overall Status:	Recruiting
Study Start:	October 27, 2020
Primary Completion:	January 2023 [Anticipated]
Study Completion:	April 2023 [Anticipated]

First Submitted:	May 18, 2020
First Submitted that Met QC Criteria:	May 20, 2020
First Posted:	May 27, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	June 10, 2022
Last Update Posted:	June 14, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Medtronic Neurovascular Clinical Affairs
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring:

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)
Detailed Description:

Conditions


Conditions:	Subdural Hematoma
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Sequential Assignment
Number of Arms:	4
Masking:	Single (Outcomes Assessor)
Allocation:	Randomized
Enrollment:	600 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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	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 [ 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


Minimum Age:	18 Years
Maximum Age:	90 Years
Sex:	All
Gender Based:
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/Locations


Central Contact Person:	Medtronic Neurovascular Clinical Affairs Telephone: 1(949) 837-3700 Email: rs.embolisestudy@medtronic.com
Study Officials:	Jared Knopman, MD Principal Investigator New York-Presbyterian Hospital/Weill Cornell Medical Center
	Jason Davies, MD Principal Investigator Buffalo General Medical Center
Locations:	United States, Alabama
	University of Alabama at Birmingham (UAB) Hospital [Recruiting] Birmingham, Alabama, United States, 35233-1932
	United States, California
	Providence Little Company of Mary Medical Center [Recruiting] Torrance, California, United States, 90503-4607
	United States, Colorado
	University of Colorado Denver School of Medicine [Recruiting] Aurora, Colorado, United States, 80045
	United States, Florida
	UF Health Heart and Vascular Hospital [Recruiting] Gainesville, Florida, United States, 32608
	Baptist Health Medical Center [Recruiting] Jacksonville, Florida, United States, 322047
	Orlando Regional Medical Center Orlando Health [Recruiting] Orlando, Florida, United States, 32806 Contact:Contact: Marshall Cress, MD
	Tampa General Hospital [Recruiting] Tampa, Florida, United States, 33606
	United States, Illinois
	Rush University Medical Center [Recruiting] Chicago, Illinois, United States, 60612
	Advocate Lutheran General Hospital [Recruiting] Park Ridge, Illinois, United States, 60068 Contact:Contact: Joshua Billingsley
	United States, Indiana
	Ascension Saint Vincent Hospital [Recruiting] Indianapolis, Indiana, United States, 46260 Contact:Contact: Daniel Sahlein, MD
	United States, Iowa
	University of Iowa Hospitals and Clinics [Recruiting] Iowa City, Iowa, United States, 52242 Contact:Contact: Kathleen Dlouhy
	United States, Kentucky
	University of Kentucky Albert B Chandler Hospital [Recruiting] Lexington, Kentucky, United States, 40506
	United States, Massachusetts
	Lahey Hospital & Medical Center [Recruiting] Burlington, Massachusetts, United States, 01805-0001
	United States, Michigan
	McLaren Flint Hospital [Recruiting] Flint, Michigan, United States, 48532 Contact:Contact: Aniel Majjhoo
	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
	North Shore University Hospital [Recruiting] Manhasset, New York, United States, 11030
	The Mount Sinai Hospital [Active, not recruiting] New York, New York, United States, 10029
	New York-Presbyterian Hospital/Weill Cornell Medical Center [Recruiting] New York, New York, United States, 10065
	Westchester Medical Center [Recruiting] Valhalla, New York, United States, 10595 Contact:Contact: Justin Santarelli
	United States, North Carolina
	Atrium Health's Carolinas Medical Center [Recruiting] Charlotte, North Carolina, United States, 28204
	United States, Ohio
	Cleveland Clinic [Recruiting] Cleveland, Ohio, United States, 44195-0001
	The Ohio State University/Wexner Medical Center [Recruiting] Columbus, Ohio, United States, 43210
	ProMedica Toledo Hospital [Recruiting] Toledo, Ohio, United States, 43606
	United States, Oklahoma
	Oklahoma University Medical Center [Recruiting] Oklahoma City, Oklahoma, United States, 73104 Contact:Contact: Hakeem Shakir
	United States, Oregon
	Oregon Health & Science University Hospital [Recruiting] Portland, Oregon, United States, 97239-3011
	United States, Pennsylvania
	University of Pittsburgh Medical Center UPMC Presbyterian [Recruiting] Pittsburgh, Pennsylvania, United States, 15213-2536
	United States, Texas
	Valley Baptist Medical Center [Recruiting] Harlingen, Texas, United States, 78550
	Baylor Scott & White Medical Center - Temple [Recruiting] Temple, Texas, United States, 76508-0001
	United States, Utah
	University of Utah Hospital [Recruiting] Salt Lake City, Utah, United States, 84132 Contact:Contact: Ramesh Grandhi, MD
	United States, Washington
	Harborview Medical Center [Recruiting] Seattle, Washington, United States, 98104-2420
	United States, Wisconsin
	Aurora Saint Luke's Medical Center [Recruiting] Milwaukee, Wisconsin, United States, 53215 Contact:Contact: Glen Pollock

IPDSharing


Plan to Share IPD:	No No individual participant data will be available

References


Citations:
Links:
Available IPD/Information: