SQUID Embolization for Subdural Hematoma

(STEM Trial)

No longer recruiting at 35 trial locations

Overseen By Amanda Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Balt USA

Disqualifiers: Craniotomy, Brain tumor, Liver impairment, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called SQUID, an embolization procedure, to determine its safety and effectiveness in managing chronic subdural hematoma (cSDH). This condition involves blood collecting on the brain's surface, causing pressure. The trial compares SQUID, which blocks the middle meningeal artery, with standard management that does not include this procedure. Suitable candidates for this trial are those with cSDH causing symptoms like headaches or balance issues, confirmed by a brain scan. As an unphased trial, it offers patients the opportunity to explore innovative treatment options for managing cSDH.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What prior data suggests that this embolization technique is safe for managing chronic subdural hematoma?

Research has shown that using SQUID for Middle Meningeal Artery (MMA) embolization safely and effectively treats chronic subdural hematoma (cSDH). Studies have found that patients generally tolerate this procedure well, with results comparable to other treatment methods. One study found that using SQUID reduces the likelihood of treatment failure, making it a promising option for patients.

Another study confirmed these findings, highlighting that MMA embolization with SQUID is a less invasive procedure that improves patient outcomes. This evidence suggests that SQUID is a dependable and safe treatment choice for those considering participation in a clinical trial for managing cSDH. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SQUID embolization for subdural hematoma because it offers a new approach by targeting the Middle Meningeal Artery (MMA) directly. Unlike traditional methods that often rely on surgical intervention to relieve pressure, SQUID uses embolization to potentially prevent further bleeding and stabilize the hematoma non-invasively. This technique could reduce recovery time and the risks associated with more invasive surgeries, providing a promising alternative for patients.

What evidence suggests that SQUID embolization is effective for chronic subdural hematoma?

Research has shown that using SQUID for treating chronic subdural hematoma (cSDH) can be effective. This trial will compare SQUID embolization, which helps prevent the hematoma from returning and reduces the need for additional surgeries, with standard management without embolization. One study found that people treated with SQUID experienced fewer serious side effects within 90 days compared to those who received standard care. Additionally, tests and check-ups at six months confirmed that SQUID is safe and effective. Overall, evidence suggests that SQUID can be a dependable treatment for cSDH. ^{1 2 3 6 7}

Who Is on the Research Team?

Adam Arthur, MD, MPH

Principal Investigator

Semmes-Murphy Neurologic and Spine Institute

David Fiorella, MD, PhD

Principal Investigator

Stony Brook University Medical Center

Are You a Good Fit for This Trial?

The STEM trial is for adults aged 30 or older with chronic subdural hematoma (cSDH) that's at least 10 mm thick and causing brain pressure. Participants must have had a stable condition before the cSDH, be experiencing symptoms like headaches or weakness, and commit to follow-up visits. Pregnant women can't join, nor can those who've had certain prior head surgeries or conditions affecting the brain.

Inclusion Criteria

I can provide a negative pregnancy test and will use birth control during the trial.

Your CT scan shows that at least half of the collection is similar or lighter in color compared to normal brain tissue.

I am 30 years old or older.

Exclusion Criteria

Subject who is currently enrolled in another investigational study protocol that could potentially confound the current study endpoints

You are expected to live for less than one year.

I have had an embolization procedure on my middle meningeal artery.

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 (MMA) embolization with SQUID or receive standard management

Immediate procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SQUID

Trial Overview

This study compares different treatments for cSDH: SQUID embolization alone, SQUID plus surgery, standard surgery alone, and medical management without surgery. Patients are randomly assigned to these groups in equal numbers to test safety and effectiveness of MMA embolization with SQUID.

How Is the Trial Designed?

Group I: SQUID Experimental Treatment 2 Interventions

Embolization of the Middle Meningeal Artery (MMA)

Group II: No Embolization Active Control 2 Interventions

Standard Management

Who Is Running the Clinical Trial?

Balt USA

Lead Sponsor

Trials

2

Recruited

910+

Balt Extrusion

Industry Sponsor

Trials

6

Recruited

11,000+

Embo-Flüssigkeiten A.G.

Industry Sponsor

Trials

2

Recruited

420+

AXIOM Real Time Metrics

Collaborator

Trials

4

Recruited

750+

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12154049/

Imaging and Clinical Outcomes Six Months After Middle ...

Conclusions: This study supports the use of MMA embolization with Squid as a safe and effective treatment for CSDH. Comparable procedural and ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/SVIN.125.001814

Consensus Statement on Middle Meningeal Artery ...

Middle meningeal artery embolization has emerged as an effective intervention in reducing hematoma recurrence and the need for rescue surgery in ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04410146

Study Details | NCT04410146 | The SQUID Trial for ...

The study objective is to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of ...

4.

nejm.org

nejm.org/doi/pdf/10.1056/NEJMoa2409845

Embolization of the Middle Meningeal Artery for Chronic ...

This trial showed that adjunctive middle men- ingeal artery embolization with the injected agent. Squid reduced the risk of treatment failure ...

5.

jnis.bmj.com

jnis.bmj.com/content/16/4/329

Middle meningeal artery embolization for chronic subdural ...

There were significantly fewer serious adverse events within 90 days in the interventional group (6.7% vs 11.6%; OR 0.54, 95% CI 0.32 to 0.92, P=0.02). The ...

6.

nejm.org

nejm.org/doi/10.1056/NEJMoa2409845

Embolization of the Middle Meningeal Artery for Chronic ...

This trial showed that adjunctive middle meningeal artery embolization with the injected agent Squid reduced the risk of treatment failure among ...

7.

pmc.ncbi.nlm.nih.gov

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

Middle meningeal artery embolization for chronic subdural ...

Secondary outcomes varied between studies, but in short, MAGIC-MT collected recurrence at 1 year, change in hematoma thickness, and modified ...