RecruitingNot ApplicableNCT06163547

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


Sponsor

University Hospital, Geneva

Enrollment

180 participants

Start Date

Feb 18, 2025

Study Type

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

Min Age: 18 YearsMax Age: 100 Years

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

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Interventions

RADIATIONMMA embolization

Middle meningeal artery embolization


Locations(2)

Geneva University Hospitals

Geneva, Switzerland

EOC

Lugano, Switzerland

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NCT06163547


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