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)
Status: Completed
Location: See all (49) locations...
Intervention Type: Procedure, Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• Pre-morbid Modified Rankin Score ≤3
• Confirmed diagnosis of subacute or chronic subdural hematoma
• Completed informed consent
• Meets criteria for Surgery or Observation Cohort
Locations
United States
Alabama
University of Alabama at Birmingham (UAB) Hospital
Birmingham
Arizona
Carondelet St. Joseph's Hospital
Tucson
California
University of California Irvine Medical Center
Irvine
USC - Keck School of Medicine
Los Angeles
Huntington Memorial Hospital
Pasadena
UCSD Medical Center
San Diego
California Pacific Medical Center
San Francisco
University of California San Francisco Medical Center
San Francisco
Providence Little Company of Mary Medical Center
Torrance
Colorado
University of Colorado Denver School of Medicine
Aurora
Florida
UF Health Heart and Vascular Hospital
Gainesville
Memorial Regional Hospital
Hollywood
Baptist Medical Center Jacksonville
Jacksonville
Jackson Memorial Hospital
Miami
Orlando Regional Medical Center Orlando Health
Orlando
Tampa General Hospital
Tampa
Saint Mary's Medical Center
West Palm Beach
Georgia
Grady Memorial Hospital
Atlanta
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Illinois
Rush University Medical Center
Chicago
Advocate Lutheran General Hospital
Park Ridge
Indiana
Ascension Saint Vincent Hospital
Indianapolis
Kentucky
University of Kentucky Albert B Chandler Hospital
Lexington
Massachusetts
Brigham and Women's Hospital
Boston
Lahey Hospital & Medical Center
Burlington
Michigan
McLaren Flint Hospital
Flint
Corewell Health
Grand Rapids
Missouri
Barnes-Jewish Hospital
St Louis
North Carolina
Atrium Health's Carolinas Medical Center
Charlotte
New York
Albany Medical Center
Albany
Buffalo General Medical Center
Buffalo
North Shore University Hospital
Manhasset
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York
The Mount Sinai Hospital
New York
Westchester Medical Center
Valhalla
Ohio
Cleveland Clinic
Cleveland
The Ohio State University/Wexner Medical Center
Columbus
ProMedica Toledo Hospital
Toledo
Oklahoma
Oklahoma University Medical Center
Oklahoma City
Oregon
Oregon Health & Science University Hospital
Portland
Pennsylvania
Geisinger Medical Center
Danville
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh
South Carolina
Prisma Health
Greenville
Texas
Valley Baptist Medical Center
Harlingen
Memorial Hermann-Texas Medical Center
Houston
Baylor Scott & White Medical Center - Temple
Temple
Utah
University of Utah Hospital
Salt Lake City
Washington
Harborview Medical Center
Seattle
Wisconsin
Aurora Saint Luke's Medical Center
Milwaukee
Time Frame
Start Date: 2020-10-27
Completion Date: 2025-04-03
Participants
Target number of participants: 600
Treatments
Active_comparator: Surgery Cohort: Control Arm
Experimental: Surgery Cohort: Treatment Arm
Active_comparator: Observational Cohort: Control Arm
Experimental: Observational Cohort: Treatment Arm
Related Therapeutic Areas
Sponsors
Leads: Medtronic Neurovascular Clinical Affairs