Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UG3NS128397 | U.S. NIH Grant/Contract | View source | |
| UH3NS128397 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to test in moderately symptomatic chronic subdural hematoma (CSDH) patients if middle meningeal artery embolization (MMAE) can be used as an alternative to conventional open surgery. The main questions it aims to answer are:
Participants will be asked to:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Middle Menningeal Artery Embolization (MMAE) | Experimental |
| |
| Conventional Surgery (Craniotomy or Burr Holes) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Surgery | Procedure | Conventional surgery is surgical drainage through burr holes or craniotomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Need for Rescue Surgery or Death | Participants who need rescue surgery or die. | Within 180-210 days of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of MMAE and Conventional Open Surgery | The proportion of subjects with symptomatic ischemic stroke, serious/life threatening adverse events, worsening of neurological status (a decline of 1 point on the Markwalder scale) or development of new disabling neurological symptoms, seizures, and/or cranial neuropathy. | Within 180 days of randomization. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Spahn | Contact | 409-266-8859 | jlspahn@utmb.edu | |
| Roberto Garcia | Contact | 409-772-3182 | robgarci@utmb.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Recruiting | Phoenix | Arizona | 85054 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Middle Meningeal Artery Embolization (MMAE) | Device | Particle embolization of the middle meningeal artery with micron variants of the Embosphere Microspheres or CONTOUR Embolization Particles device. |
|
| Baptist Medical Center Jacksonville | Recruiting | Jacksonville | Florida | 32207 | United States |
|
| University of Miami Miller School of Medicine | Recruiting | Miami | Florida | 33136 | United States |
|
| University of South Florida | Recruiting | Tampa | Florida | 33617 | United States |
|
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 61660 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| University of Minnesota | Withdrawn | Minneapolis | Minnesota | 55455 | United States |
| University of Missouri Healthcare | Recruiting | Columbia | Missouri | 65212 | United States |
|
| Washington University, St. Louis | Recruiting | St Louis | Missouri | 63110 | United States |
|
| Cooper University Hospital | Recruiting | Camden | New Jersey | 08103 | United States |
|
| JFK Neuroscience Institute, JFK University Medical Center | Recruiting | Edison | New Jersey | 08820 | United States |
|
| Rutgers, The State University of New Jersey | Recruiting | Newark | New Jersey | 07101 | United States |
|
| Ichan School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| SUNY Upstate Medical University | Active, not recruiting | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
|
| Westchester Medical Center | Recruiting | Valhalla | New York | 10595 | United States |
|
| Wake Forest University | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| Good Samaritan Hospital | Recruiting | Cincinnati | Ohio | 45220 | United States |
|
| Mercy Health St. Vincent Medical Center | Not yet recruiting | Toledo | Ohio | 43608 | United States |
|
| University of Pennyslvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Philadelphia Neurological Institute | Recruiting | Upland | Pennsylvania | 19013 | United States |
|
| UT Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
|
| University of Texas Medical Branch | Recruiting | Galveston | Texas | 77555 | United States |
|
| University of Texas Health Science Center-Houston | Recruiting | Houston | Texas | 77030 | United States |
|
| University of Texas Health Science Center-San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| University of Utah | Recruiting | Salt Lake City | Utah | 84132 | United States |
|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
|
| University of Washington | Recruiting | Seattle | Washington | 98104 | United States |
|
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
Not provided
Not provided