History of Changes for Study: NCT04402632

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

Latest version (submitted February 6, 2024) on ClinicalTrials.gov

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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

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Study NCT04402632
Submitted Date: September 25, 2020 (v3)

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:	September 2020
Overall Status:	Recruiting
Study Start:	September 2020
Primary Completion:	December 2022 [Anticipated]
Study Completion:	March 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:	September 25, 2020
Last Update Posted:	September 29, 2020 [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:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Sequential Assignment
Number of Arms:	4
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	600 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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	No Treatment Observation Only (Control)
Experimental: Observational Cohort: Treatment Arm Treatment	Device: Treatment 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-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

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, Kentucky
	University of Kentucky Albert B Chandler Hospital [Recruiting] Lexington, Kentucky, United States, 40506

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