Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)
Middle Meningeal Artery (MMA) Embolization for cSDH: Rationale and Design for the STOp Recurrence of MMA Bleeding (STORMM) Randomized-Control Trial
University Hospital, Geneva
180 participants
Feb 18, 2025
INTERVENTIONAL
Conditions
Summary
Chronic Subdural Hematomas (cSHD) are common, and due to cerebral compression, often result in neurological impairment and reduced consciousness. Surgery is typically performed once neurological symptoms develop. Recent studies suggest that arteries nourished by the middle meningeal artery (MMA) may be responsible for hematoma progression and that MMA embolization is clinically useful. There is less evidence, that embolization of MMA also may be a treatment option for individuals without surgical treatment. The investigators propose a multicentre study to investigate both potentials: (1) Assessment of efficacy of embolization after surgery to reduce recurrence and improve outcomes by conducting a randomized trial (randomization arms; Arms 1 and 2), (2) Assessment of embolization-alone efficacy when surgery is contraindicated or refused (embolization-only arm, Arms 3 and 4).
Eligibility
Inclusion Criteria5
- 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 Criteria6
- Consent not possible
- Pregnancy
- Prisoner
- Angiography contraindication
- Patient for whom follow-up is problematic (e.g. distant residency, homeless …)
- Previous surgery for cSDH
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Middle meningeal artery embolization
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06163547