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

Subdural Hematoma Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04402632
• Other study ID #: MDT19027ONYX
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: Medtronic Neurovascular Clinical Affairs
• Phone: 1(949) 837-3700
• Email: rs.embolisestudy[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematoma
• Hematoma, Subdural, Chronic
• Subdural Hematoma

Intervention

Procedure:
• Surgical Management
SDH Evacuation (Control)

Device:
• Surgical Management + Treatment
SDH Evacuation + Onyx™ LES Embolization

Other:
• No Treatment
Observation Only (Control)

Device:
• Treatment
Onyx™ LES Embolization

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	University of Colorado Denver School of Medicine	Aurora	Colorado
United States	University of Alabama at Birmingham (UAB) Hospital	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Buffalo General Medical Center	Buffalo	New York
United States	Lahey Hospital & Medical Center	Burlington	Massachusetts
United States	Atrium Health's Carolinas Medical Center	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University/Wexner Medical Center	Columbus	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	McLaren Flint Hospital	Flint	Michigan
United States	UF Health Heart and Vascular Hospital	Gainesville	Florida
United States	Spectrum Health Hospital	Grand Rapids	Michigan
United States	Prisma Health	Greenville	South Carolina
United States	Valley Baptist Medical Center	Harlingen	Texas
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Memorial Hermann-Texas Medical Center	Houston	Texas
United States	Ascension Saint Vincent Hospital	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of California Irvine Medical Center	Irvine	California
United States	Baptist Medical Center Jacksonville	Jacksonville	Florida
United States	University of Kentucky Albert B Chandler Hospital	Lexington	Kentucky
United States	USC - Keck School of Medicine	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Jackson Memorial Hospital	Miami	Florida
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	New York-Presbyterian Hospital/Weill Cornell Medical Center	New York	New York
United States	The Mount Sinai Hospital	New York	New York
United States	Oklahoma University Medical Center	Oklahoma City	Oklahoma
United States	Orlando Regional Medical Center Orlando Health	Orlando	Florida
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	Huntington Memorial Hospital	Pasadena	California
United States	University of Pittsburgh Medical Center UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University Hospital	Portland	Oregon
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	University of Utah Hospital	Salt Lake City	Utah
United States	UCSD Medical Center	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	University of California San Francisco Medical Center	San Francisco	California
United States	Harborview Medical Center	Seattle	Washington
United States	Tampa General Hospital	Tampa	Florida
United States	Baylor Scott & White Medical Center - Temple	Temple	Texas
United States	ProMedica Toledo Hospital	Toledo	Ohio
United States	Providence Little Company of Mary Medical Center	Torrance	California
United States	Carondelet St. Joseph's Hospital	Tucson	Arizona
United States	Westchester Medical Center	Valhalla	New York
United States	Saint Mary's Medical Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness: Incidence of hematoma recurrence/progression requiring re-intervention		90 days post-procedure
Secondary	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
Secondary	Effectiveness: Incidence of hospital readmissions		90 days post-procedure
Secondary	Effectiveness: Change in hematoma volume based on CT/MRI imaging		90 days post-procedure
Secondary	Effectiveness: Change in hematoma thickness per CT/MRI imaging		90 days post-procedure
Secondary	Effectiveness: Change in midline shift based on CT/MRI imaging		90 days post-procedure
Secondary	Safety: Incidence of device-related serious adverse events		30 days post-procedure
Secondary	Safety: Incidence of procedure-related serious adverse events		30 days post-procedure
Secondary	Safety: Incidence of neurological death		90 days and 180 days post-procedure
Secondary	Safety: Incidence of device-related adverse events		90 days and 180 days post-procedure