Embolization of the middle meningeal artery for treating chronic subdural hematomas
Middle Meningeal Artery (MMA) Embolization for cSDH: Rationale and Design for the STOp Recurrence of MMA Bleeding (STORMM) Randomized-Control Trial
This study is testing if blocking a specific artery can help people with chronic subdural hematomas either when combined with surgery or as a standalone treatment for those who can’t have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Geneva and 1 other locations) |
| Trial ID | NCT06163547 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy of middle meningeal artery (MMA) embolization in patients with chronic subdural hematomas (cSDH). It aims to evaluate the recurrence rates of cSDH after combined surgical and MMA embolization treatments compared to surgery alone. Additionally, the study assesses the effectiveness of MMA embolization as a standalone treatment for patients who cannot undergo surgery. The research involves a multicenter randomized control trial to provide higher-level evidence regarding the safety and efficacy of this intervention.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-100 with symptomatic chronic subdural hematomas located at the convexities.
Not a fit: Patients who may not benefit include those who cannot provide consent, are pregnant, or have contraindications for angiography.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence rates of chronic subdural hematomas, potentially improving patient outcomes and reducing the need for additional surgeries.
How similar studies have performed: While there is limited evidence supporting the efficacy of MMA embolization, previous case series suggest lower recurrence rates, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18-100 * Consent possible * cSDH located at the convexities * Patients with symptomatic cSDH * Patients with asymptomatic large chronic/subacute hematoma after 6 weeks of failed conservative treatment Exclusion Criteria: * Consent not possible * Pregnancy * Prisoner * Angiography contraindication * Patient for whom follow-up is problematic (e.g. distant residency, homeless …) * Previous surgery for cSDH
Where this trial is running
Geneva and 1 other locations
- Geneva University Hospitals — Geneva, Switzerland (Recruiting)
- Eoc — Lugano, Switzerland (Recruiting)
Study contacts
- Principal investigator: Aria Nouri — University Hospital, Geneva
- Study coordinator: Aria Nouri
- Email: aria.nouri@hug.ch
- Phone: +41795530958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.