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due to reason 3 in the protocol- any new information becomes available during the trial that necessitates stopping the trial. New information became available with device no longer being investigational.
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Endovascular middle meningeal artery (MMA) embolization is an emerging treatment for chronic subdural hematoma (cSDH). There is preliminary data to suggest that this minimally invasive therapy may be more efficacious and equally as safe compared to conventional, more invasive surgery. This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma as an adjunct to standard treatments, which include medical management and surgical evacuation.
This study seeks to assess the safety and efficacy of middle meningeal artery embolization for chronic subdural hematoma in addition to standard treatments, which include close observation and surgical evacuation. Middle meningeal artery embolization has emerged recently as a minimally invasive and successful method of preventing re-accumulation of subdural hematoma, particularly for patients that are not obvious surgical candidates or those with recurrent or refractory hematomas. The outcomes of these two groups of patients who undergo middle meningeal artery embolization will be compared to matched historical controls.
Middle meningeal artery embolization is a minimally invasive angiography procedure completed with use of fluoroscopy. Access is obtained through the femoral or radial artery and a catheter is advanced to the MMA. Polyvinyl alcohol particles are then injected to seal off this portion of the artery and prevent any further blood flow into the subdural hematoma. Hemostasis is obtained at the access site and the patient is observed for 24-48 hours on a neurological care unit before discharge.
A head CT, NIHSS, and modified Rankin Score will be repeated on the following schedule: • Pre-Procedure
Patients with chronic subdural hematoma undergo CT scans and neurologic assessments on hospital admission, as well as follow up CT scans and neurologic assessments to assess for any change in neurologic status or hematoma size. This study utilizes a standard of care follow up schedule to avoid exposing participants to extra radiation. Participants will be followed for study related purposes for 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embolization Only | Medically managed patient receives middle meningeal artery embolization |
| |
| Embolization + Evacuation | Participant receives standard of care evacuation and then undergoes MMA embolization |
| |
| Medical Management | Historical control of medically managed patients | ||
| Surgical Patients | Historical control of patients receiving standard surgery alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA) | Procedure | Seal off blood supply to the middle meningeal artery to prevent growth of subdural hematoma |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with recurrent or refractory hematoma (Radiographic resolution) | The subdural hematoma persists or reoccurs | A head CT will be repeated 24 hours after the procedure, 7-10 days, 30 days, and 90 days post procedure to measure any change in size of the SDH compared to pre-procedure size |
| Number of patients requiring secondary evacuation surgery (Treatment Efficacy) | The participant requires a post-procedure (post-MMA embolization) evacuation of the subdural hematoma due to re-occurrence or persistence of hematoma and symptoms | Evacuation surgery required within the 90 day follow up period |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related complication rate (Safety) | Complication rate of embolization procedure vs surgery | Procedure-related complications will be compared between embolization and historical surgical patients assessed through study completion, 90 days |
| Change in NIH Stroke Scale Score (Functional outcome) |
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Inclusion Criteria:
and
Exclusion Criteria:
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number of participants reflects population with diagnosis
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| Name | Affiliation | Role |
|---|---|---|
| Joshua W Osbun, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 2, 2020 | Jul 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2025 | Jul 14, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| D011145 | Polyvinyls |
| D000431 | Ethanol |
| D011142 | Polyvinyl Alcohol |
| D051184 | Desmoglein 3 |
| D003399 | Craniotomy |
| ID | Term |
|---|---|
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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| Drainage of Subdural Hematoma | Procedure | Drainage of subdural hematoma via burrhole or craniotomy |
|
|
Change in score on National Institutes of Health Stroke Scale. The NIH Stroke Scale is used to quantify neurologic impairments. It consists of 11 items each scored between 0 and 4 points. The maximum score is 42, indicating severe impairment, and the minimum score is 0. Stroke severity 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke |
| Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure |
| Change in modified Rankin Scale (Functional outcome) | Change in score on modified Rankin Scale The modified Rankin Scale (mRS) measures the degree of disability or dependence after a stroke or other neurologic disease. The scale runs from 0-6, with 0 indicating perfect health with no symptoms to 6 indicating death. 0 - No symptoms.
| Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure |
| Change in size of subdural hematoma | CT scan measurements of size of subdural hematoma | Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure |
| 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 |
| D009930 |
| Organic Chemicals |
| D014753 | Vinyl Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000438 | Alcohols |
| D051182 | Desmogleins |
| D051181 | Desmosomal Cadherins |
| D015820 | Cadherins |
| D015815 | Cell Adhesion Molecules |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D001324 | Autoantigens |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |