Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

NCT04065113 | Withdrawn FDA Device

• 1 other identifier: 201905146
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Procedure-related complication rate (Safety)

  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)

  Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure

• Change in modified Rankin Scale (Functional outcome)

  Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure

• Change in size of subdural hematoma

  Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure

Study Arms (4)

Embolization Only

Medically managed patient receives middle meningeal artery embolization

Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA)

Embolization + Evacuation

Participant receives standard of care evacuation and then undergoes MMA embolization

Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA); Procedure: Drainage of Subdural Hematoma

Medical Management

Historical control of medically managed patients

Surgical Patients

Historical control of patients receiving standard surgery alone

Procedure: Drainage of Subdural Hematoma

Interventions

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

Also known as: MMA Embolization with polyvinyl alcohol (PVA) particles

Embolization + Evacuation; Embolization Only

Drainage of Subdural Hematoma PROCEDURE

Drainage of subdural hematoma via burrhole or craniotomy

Also known as: Burr Hole Drainage, Craniotomy

Embolization + Evacuation; Surgical Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

number of participants reflects population with diagnosis

You may qualify if:

• Patients 18 years or older undergoing treatment for a new diagnosis of chronic subdural hematoma (cSDH) or
• Patients 18 year or older who have undergone surgical evacuation of a subdural hematoma and have a significant residual hematoma status post-surgery or who develop a recurrent subdural hematoma.
• and
• Minimal symptoms such as headache, altered mental status, or mild neurological deficit only
• Ability to understand and sign written informed consent by patient or LAR

You may not qualify if:

• Significant midline shift and/or neurologic symptoms requiring urgent decompression.
• Common carotid stenosis of over 50%.
• Significant contraindication to angiography (eg. kidney failure, difficult anatomy).
• SDH related to underlying condition
• Acute SDH

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Polyvinyls; Ethanol; Polyvinyl Alcohol; Desmoglein 3; Craniotomy

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Vinyl Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Alcohols; Desmogleins; Desmosomal Cadherins; Cadherins; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Surface; Antigens; Biological Factors; Autoantigens; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Joshua W Osbun, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 22, 2019
• Study Start: September 19, 2019
• Primary Completion: August 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)