Middle Meningeal Artery Embolization for Chronic Subdural Hematoma

July 16, 2025 updated by: Washington University School of Medicine

Middle Meningeal Artery (MMA) Embolization for Patients With Chronic Subdural Hematoma (cSDH)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

  • 24 hours post procedure
  • 7-10 days post procedure
  • 30 days post procedure
  • 90 days post 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

number of participants reflects population with diagnosis

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Embolization Only
Medically managed patient receives middle meningeal artery embolization
Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA)
Seal off blood supply to the middle meningeal artery to prevent growth of subdural hematoma
Other Names:
  • MMA Embolization with polyvinyl alcohol (PVA) particles
Embolization + Evacuation
Participant receives standard of care evacuation and then undergoes MMA embolization
Procedure: Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA)
Seal off blood supply to the middle meningeal artery to prevent growth of subdural hematoma
Other Names:
  • MMA Embolization with polyvinyl alcohol (PVA) particles
Procedure: Drainage of Subdural Hematoma
Drainage of subdural hematoma via burrhole or craniotomy
Other Names:
  • Burr Hole Drainage
  • Craniotomy
Medical Management
Historical control of medically managed patients
Surgical Patients
Historical control of patients receiving standard surgery alone
Procedure: Drainage of Subdural Hematoma
Drainage of subdural hematoma via burrhole or craniotomy
Other Names:
  • Burr Hole Drainage
  • Craniotomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients with recurrent or refractory hematoma (Radiographic resolution)
Time Frame: 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
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)
Time Frame: Evacuation surgery required within the 90 day follow up period
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure-related complication rate (Safety)
Time Frame: Procedure-related complications will be compared between embolization and historical surgical patients assessed through study completion, 90 days
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)
Time Frame: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure

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)
Time Frame: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure

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.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
Change in size of subdural hematoma
Time Frame: Compared pre-procedure, 24 hours post-procedure, 7-10 days, 30 days, and 90 days post-procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joshua W Osbun, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201905146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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