SQUID Embolization for Subdural Hematoma

(STEM Trial)

Recruiting at 33 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

310 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a procedure that blocks a brain artery using SQUID to help patients with long-term brain bleeding. The goal is to see if this method is safe and effective.

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 data supports the effectiveness of the treatment SQUID for subdural hematoma?

Research shows that using SQUID for middle meningeal artery embolization in older patients with chronic subdural hematoma significantly reduced the size of the hematoma without complications. This suggests that SQUID can be an effective treatment option for managing subdural hematomas. ^{1 2 3 4 5}

Is SQUID embolization safe for treating subdural hematomas?

Research shows that SQUID embolization is generally safe for treating chronic subdural hematomas, with studies reporting no complications during or after the procedure and significant reduction in hematoma size. In one study, patients over 80 experienced no complications, and another study found it to be a safe alternative treatment option. ^{3 6 7 8 9}

How is the SQUID treatment different from other treatments for subdural hematoma?

SQUID treatment for subdural hematoma is unique because it involves a minimally invasive procedure called embolization, where a liquid agent is used to block blood flow in the middle meningeal artery, helping to reduce the hematoma without the need for direct surgical removal. This approach is particularly beneficial for elderly patients, as it offers a safer alternative with fewer complications compared to traditional surgical methods. ^{2 3 7 10 11}

Research Team

David Fiorella, MD, PhD

Principal Investigator

Stony Brook University Medical Center

Adam Arthur, MD, MPH

Principal Investigator

Semmes-Murphy Neurologic and Spine Institute

Eligibility Criteria

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

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

You are expected to live for less than one year.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

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]

References

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

Primary Middle Meningeal Artery Embolization for a Chronic Subdural Hematoma After Non-Accidental Trauma in a Child: A Case Report. [2022]

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

Middle Meningeal Artery Embolization for Chronic Subdural Hematoma. [2023]

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

Safety and radiologic clearance of chronic subdural hematoma after endovascular embolization using SQUID 18 in patients older than 80 years. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Middle meningeal artery embolization in pediatric patient. [2022]

5. 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]

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

Acute nontraumatic subdural hematoma from ruptured accessory meningeal artery pseudoaneurysm. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Endovascular Treatment of Chronic Subdural Hematomas through Embolization: A Pilot Study with a Non-Adhesive Liquid Embolic Agent of Minimal Viscosity (Squid). [2021]

8. Turkey pubmed.ncbi.nlm.nih.gov

Preliminary experience with squid: a new liquid embolizing agent for AVM, AV fistulas and tumors. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Middle meningeal artery embolisation for chronic subdural haematomas: the first prospective UK study. [2023]

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

CTA-Based Patient-Tailored Femoral or Radial Frontline Access Reduces the Rate of Catheterization Failure in Chronic Subdural Hematoma Embolization. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

Awake transradial middle meningeal artery embolization and twist drill craniostomy for chronic subdural hematomas in the elderly: case series and technical note. [2023]