Middle Meningeal Artery Embolization for Subdural Hematoma

(EMBOLISE Trial)

No longer recruiting at 51 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat subacute or chronic subdural hematomas, which are blood collections on the brain's surface that can cause pressure. Researchers are testing whether a procedure using the Onyx™ Liquid Embolic System, which blocks blood flow in a specific artery, is safe and effective. Participants may be assigned to different groups to receive either this new treatment or a standard surgical management approach. The trial seeks individuals diagnosed with a subacute or chronic subdural hematoma who do not have severe disability from it. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options.

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 prior data suggests that the Onyx™ Liquid Embolic System is safe for treating subdural hematoma?

Research has shown that the Onyx™ Liquid Embolic System, used for treating certain blood vessels in the brain, is generally well-tolerated. In earlier studies, patients maintained good brain function and experienced fewer problems, indicating that their brain health improved or remained stable.

Safety information from these studies indicates a low risk of serious side effects with this treatment. It reduces the need for additional surgery by lowering the chance of recurrence.

Overall, the treatment is considered a safe option for individuals with subdural hematomas, which are blood collections on the brain's surface. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment for subdural hematoma, which often involves surgery to remove the blood accumulation, the Onyx™ Liquid Embolic System offers a minimally invasive alternative. Researchers are excited because this system targets the middle meningeal artery, potentially stopping the bleeding at its source and reducing the need for surgery. By using a liquid embolic agent, it can precisely seal off the bleeding vessel, which may lead to faster recovery times and fewer complications compared to traditional surgical methods.

What evidence suggests that the Onyx™ Liquid Embolic System is effective for treating subdural hematoma?

Research has shown that the Onyx™ Liquid Embolic System is a promising treatment for subdural hematoma, a type of brain bleed. In this trial, some participants will receive the Onyx treatment, which studies have found can reduce the risk of the hematoma recurring or worsening. One study found that patients who received this treatment along with surgery were less likely to need another operation. Another study supported these results by showing a lower rate of repeat surgeries in patients treated with Onyx. These findings suggest that Onyx may help stabilize or shrink the hematoma, making it a potentially effective treatment option. ^{1 2 3 6 7}

Who Is on the Research Team?

Jason Davies, MD

Principal Investigator

Buffalo General Medical Center

Jared Knopman, MD

Principal Investigator

New York-Presbyterian Hospital/Weill Cornell Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12152056/

Middle meningeal artery embolization for chronic subdural ... The primary outcomes were defined as follows: In the MAGIC-MT trial (Onyx™); symptomatic recurrence or progression of the subdural hematoma ( ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2313472

Adjunctive Middle Meningeal Artery Embolization for ... Middle meningeal artery embolization plus surgery was associated with a lower risk of hematoma recurrence or progression leading to reoperation than surgery ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04402632

Study Details | NCT04402632 | Embolization of the Middle ... 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 ...

4. ahajournals.org ahajournals.org/doi/10.1161/SVIN.125.001828

Middle Meningeal Artery Embolization With n‐Butyl ... Studies evaluating the Onyx Liquid Embolic System showed a reduction in reoperation rate in surgical patients (EMBOLISE [A Study of the ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0967586825006241

Does the volume of Onyx injected influence outcomes after ... Recent literature has highlighted the efficacy of liquid embolic agents like Onyx for middle meningeal artery (MMA) embolization of subdural hematoma (SDH).

6. ahajournals.org ahajournals.org/doi/10.1161/SVIN.125.001814

Consensus Statement on Middle Meningeal Artery ... Middle meningeal artery embolization provides a promising, minimally invasive option that improves patient outcomes and reduces the need for ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2589238X24000883

Efficacy and safety of middle meningeal artery ... Middle meningeal artery embolization, when combined with burr hole craniostomy, represents a safe and effective approach for managing CSDH, resulting in ...