Middle Meningeal Artery Embolization for Subdural Hematoma

(EMBOLISE Trial)

Recruiting at 50 trial locations

Overseen By Medtronic Neurovascular Clinical Affairs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Neurovascular Clinical Affairs

Must not be taking: Corticosteroids

Disqualifiers: Pregnancy, Acute SDH, Tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

600 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)

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

The trial does not specify if you need to stop taking your current medications, but you must be able to stop taking corticosteroids for at least 90 days after joining the trial.

What data supports the effectiveness of the treatment Onyx™ Liquid Embolic System for Middle Meningeal Artery Embolization in treating Subdural Hematoma?

Research shows that middle meningeal artery embolization, which includes using liquid embolic agents like Onyx™, is becoming a popular and effective treatment for chronic subdural hematomas, with studies indicating positive outcomes in reducing hematoma size and improving patient conditions. ^{1 2 3 4 5}

Is middle meningeal artery embolization generally safe for humans?

Middle meningeal artery embolization is considered a minimally invasive treatment and has been studied for its safety in managing subdural hematomas. Research indicates it is generally safe, with studies systematically reviewing its safety and effectiveness, even in patients with other health conditions. ^{1 2 6 7 8}

How is the treatment Onyx™ Liquid Embolic System different from other treatments for subdural hematoma?

The Onyx™ Liquid Embolic System is unique because it involves a minimally invasive procedure called middle meningeal artery embolization, which targets the blood vessels supplying the hematoma to prevent recurrence, unlike traditional surgical methods that physically remove the hematoma. ^{1 6 8 9 10}

Research Team

Jared Knopman, MD

Principal Investigator

New York-Presbyterian Hospital/Weill Cornell Medical Center

Jason Davies, MD

Principal Investigator

Buffalo General Medical Center

Eligibility Criteria

This trial is for individuals with a confirmed diagnosis of subacute or chronic subdural hematoma, who are relatively independent in daily activities (Modified Rankin Score ≤3), and can consent to treatment. Excluded are those with life expectancy <1 year, severe symptoms (Markwalder score ≥ 3), active COVID-19, pregnancy, acute SDH, uncontrolled bleeding disorders, suspected infections within the brain, unsafe anatomy for the procedure, tumors or mass lesions in the brain, contraindications to angiography or Onyx™ LES use.

Inclusion Criteria

I was mostly independent in daily activities before my current illness.

I am eligible for either surgery or observation.

Completed informed consent

Exclusion Criteria

Pregnant, lactating, or has a positive pregnancy test at time of admission

You have a Markwalder Grading Scale score of 3 or higher before the randomization.

I cannot use Onyx™ LES due to health reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo embolization of the middle meningeal artery using the Onyx™ Liquid Embolic System for treatment of subacute or chronic subdural hematoma

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

3 visits (in-person)

Treatment Details

Interventions

• Onyx™ Liquid Embolic System
• Surgical Management

Trial Overview The study tests if blocking blood flow to the affected area using Onyx™ Liquid Embolic System through embolization of middle meningeal artery is safe and effective for treating symptomatic subacute/chronic subdural hematomas compared to no treatment or standard surgical management.

Participant Groups

Group I: Surgery Cohort: Treatment Arm Experimental Treatment 1 Intervention

Treatment

Group II: Observational Cohort: Treatment Arm Experimental Treatment 1 Intervention

Treatment

Group III: Surgery Cohort: Control Arm Active Control 1 Intervention

Control

Group IV: Observational Cohort: Control Arm Active Control 1 Intervention

Control

Who Is Running the Clinical Trial?

Medtronic Neurovascular Clinical Affairs

Lead Sponsor

Trials

32

Recruited

10,000+

Findings from Research

Middle meningeal artery embolization is a safe and effective treatment for chronic subdural hematomas, showing a low recurrence rate of 4.1% and a reoperation rate of 4.2% among 382 patients studied.

Using Onyx as the embolic agent resulted in the lowest rates of recurrence and complications, while a combination of polyvinyl alcohol and coils led to the best overall clinical outcomes, suggesting that the choice of embolic agent can significantly impact treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embolic Agent Choice in Middle Meningeal Artery Embolization as Primary or Adjunct Treatment for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. Ku, JC., Dmytriw, AA., Essibayi, MA., et al.[2023]

Middle meningeal artery embolization is increasingly recognized as a primary treatment for chronic subdural hematomas, with a growing body of literature supporting its use.

The authors present a case series of 11 patients undergoing this procedure, contributing to the understanding of its advantages and technical aspects in the context of existing studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Middle meningeal artery embolization for chronic subdural haematoma. Case series and literature review]. Stanishevskiy, AV., Babichev, KN., Vinogradov, EV., et al.[2021]

MMA embolization is a safe and effective minimally invasive treatment for chronic subdural hematomas (cSDH), with a median reduction of 77.5% in hematoma size and a 72.8% rate of over 50% improvement in imaging results after the procedure.

Out of 144 patients treated, only 13.8% required retreatment for recurrent issues, and complications were low at 2.8%, indicating a favorable safety profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle meningeal artery embolization without surgical evacuation for chronic subdural hematoma: a single-center experience of 209 cases. Orscelik, A., Senol, YC., Bilgin, C., et al.[2023]

MMA embolization is a safe and effective treatment for chronic subdural hematoma (CSDH), with a low recurrence rate of 3.6% and no reported complications in a review of 15 studies involving 193 procedures.

In our clinical experience with 8 patients treated using Onyx, all experienced symptom relief and significant reduction in hematoma size, further supporting the efficacy of this minimally invasive approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Embolization for Chronic Subdural Hematoma: Systematic Review and Case Series. Waqas, M., Vakhari, K., Weimer, PV., et al.[2020]

In a study of 61 patients with recurrent subdural hematoma, MMA embolization using diluted n-butyl cyanoacrylate (n-BCA) achieved complete obliteration of the targeted arteries in 100% of cases, demonstrating high efficacy in preventing further bleeding.

The procedure showed a low complication rate, with only 5% of patients experiencing recurrence of subdural hematoma and minimal risks of serious side effects such as cranial nerve palsy or stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma Using N-Butyl Cyanoacrylate With D5W Push Technique. Majidi, S., Matsoukas, S., De Leacy, RA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Embolic Agent Choice in Middle Meningeal Artery Embolization as Primary or Adjunct Treatment for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization with Liquid Embolic Agents for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. [2023]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Middle meningeal artery embolization for chronic subdural haematoma. Case series and literature review]. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization Using Combined Particle Embolization and n-BCA with the Dextrose 5% in Water Push Technique for Chronic Subdural Hematomas: A Prospective Safety and Feasibility Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Radiographic and clinical outcomes with particle or liquid embolic agents for middle meningeal artery embolization of nonacute subdural hematomas. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Middle meningeal artery embolization without surgical evacuation for chronic subdural hematoma: a single-center experience of 209 cases. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Transradial middle meningeal artery embolization for chronic subdural hematoma using Onyx: case series. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Embolization for Chronic Subdural Hematoma: Systematic Review and Case Series. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization for Membranous Versus Nonmembranous Subdural Hematomas: A Retrospective and Multicenter Cohort Study. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma Using N-Butyl Cyanoacrylate With D5W Push Technique. [2022]