5000 Participants Needed

Middle Meningeal Artery Embolization for Subdural Hematoma

(MESH Trial)

Recruiting at 10 trial locations
MA
Overseen ByMuhammed Amir Essibayi, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Montefiore Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of middle meningeal artery embolization (MMAE) for individuals with chronic subdural hematoma (cSDH), a condition where blood collects on the brain's surface, causing pressure and headaches. Researchers aim to determine the treatment's effectiveness, recurrence rate, and safety. Individuals who have previously received this treatment using common materials like particles or glue may be suitable candidates for the study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to early-stage findings.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for treating subdural hematoma?

Research has shown that Middle Meningeal Artery Embolization (MMAE) is generally safe for treating chronic subdural hematoma (CSDH). One study found that this method works well and is tolerated by many patients. Another report noted that serious complications are rare, with only about 4.1% of patients needing additional treatment after the procedure.

While some risks exist, such as a small number of deaths in trials, these were similar to those in groups not receiving the procedure and may not be directly related to MMAE. Overall, MMAE is considered a safe option for managing CSDH, even in older adults.12345

Why are researchers excited about this trial?

Middle Meningeal Artery Embolization (MMAE) is unique because it offers a minimally invasive approach to treating chronic subdural hematoma (cSDH), a condition often managed with surgery like burr hole drainage or craniotomy. Unlike these surgical methods, MMAE works by blocking the middle meningeal artery, which can help reduce the bleeding and pressure causing the hematoma. Researchers are excited about MMAE because it potentially reduces recovery time and surgical risks, offering a safer and quicker alternative for patients.

What evidence suggests that middle meningeal artery embolization is effective for subdural hematoma?

Studies have shown that Middle Meningeal Artery Embolization (MMAE) effectively treats chronic subdural hematoma, a condition where blood collects between the brain and its outer covering. Research indicates that MMAE reduces the likelihood of recurrence compared to surgery alone. Some studies even suggest it could become a common treatment option. MMAE is also safe for older adults, making it suitable for those who might not tolerate surgery well. Overall, MMAE shows promise in managing this condition, especially for high-risk patients.23456

Who Is on the Research Team?

DA

David Altschul, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

You are 18 years old or older.
You have been treated with certain types of medical devices or substances.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Middle Meningeal Artery Embolization (MMAE) for chronic subdural hematoma

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical outcomes and complications

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Middle Meningeal Artery Embolization (MMAE)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials
468
Recruited
599,000+

Geisinger Clinic

Collaborator

Trials
159
Recruited
1,976,000+

Heidelberg University

Collaborator

Trials
403
Recruited
277,000+

Henri Mondor University Hospital

Collaborator

Trials
66
Recruited
52,600+

Ospedale Policlinico San Martino

Collaborator

Trials
53
Recruited
431,000+

Ospedale San Raffaele

Collaborator

Trials
86
Recruited
388,000+

Lehigh Valley Hospital

Collaborator

Trials
26
Recruited
21,700+

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+

Medical University of South Carolina

Collaborator

Trials
994
Recruited
7,408,000+

New York University

Collaborator

Trials
249
Recruited
229,000+

Citations

Middle meningeal artery embolization for chronic subdural ...

While surgical intervention is effective, recurrence ranges between 6 and 15% [15, 17, 18, 40, 50]. Middle Meningeal Artery embolization (MMAE) ...

Middle meningeal artery embolization for chronic subdural ...

MMA embolization is safe and effective in the nonagenarian population. · MMA embolization may be applied as primary or adjunctive treatment. · Multiple sedation/ ...

Embolization of the Middle Meningeal Artery for Chronic ...

Among patients with symptomatic chronic subdural hematoma, adjunctive middle meningeal artery embolization resulted in a lower risk of treatment ...

Consensus Statement on Middle Meningeal Artery ...

These results suggest that MMAE plus standard treatment of CSDH shows promising results and may become a standard of care for managing CSDH in ...

Middle Meningeal Artery Embolization for Management of ...

Middle meningeal artery embolization shows promise as an effective option for management of chronic subdural hematoma, particularly in patients at high risk ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39681110/

Efficacy and Safety of Middle Meningeal Artery ...

Conclusion: MMA embolization in CSDH management is a safe and effective approach for CSDH. Keywords: Best medical management; Chronic subdural ...