Clinical trial NCT04816591: Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
Official title: Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: Chronic Subdural Hematoma, MMA Embolization
Lead sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).

Detailed description: This is a prospective, multi-center, open-label, randomized controlled study in which up to 376 subjects will be randomized to receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of cSDH.

Eligibility criteria: Inclusion Criteria:

* Pre-randomization mRS \</= 3
* Confirmed diagnosis of chronic subdural hematoma
* Completed informed consent

Exclusion Criteria:

* Acute subdural hematoma
* Prior treatment of target subdural hematoma
* Markwalder assessment \>/= 3
* Glasgow Coma Scale \< 9
* Presumed microbial superinfection
* CT or MRI evidence of intracranial tumor or mass lesion
* Life expectancy \< 1 year
* Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study
* Current involvement in another clinical trial that may confound study endpoints

Primary outcomes:
measure: Effectiveness
timeFrame: 180 days post procedure
Secondary outcomes:
measure: Effectiveness
timeFrame: 180 days post procedure
measure: Safety: Change in mRS
timeFrame: 180 days post procedure
Other outcomes:
measure: Health Economics
timeFrame: 365 days post procedure
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: Carondelet St Joseph's Hospital
state: Arizona
city: Walnut Creek
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami - Jackson Memorial Hospital
state: Florida
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Marietta
country: United States
facility: Wellstar Health System
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Health Center
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio Health
state: Ohio
city: Toledo
country: United States
facility: Mercy Health St Vincent Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital of Research
state: Pennsylvania
city: Memphis
country: United States
facility: Semmes Murphey Foundation
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Plano
country: United States
facility: Texas Stroke Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia School of Medicine
state: Virginia
city: Morgantown
country: United States
facility: West Virginia Hospital
state: West Virginia
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Christopher Kellner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Virginia University
name: Ansaar Rai, MD
role: PRINCIPAL_INVESTIGATOR
References: