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ClinicalTrials.gov ID

NCT06163547

Lead Sponsor

University Hospital, GenevaOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

180Estimated

Last Update Posted

Mar 17, 2026Actual

Start Date

Feb 18, 2025Actual

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Jan 1, 2027Estimated

Official Title

Middle Meningeal Artery (MMA) Embolization for cSDH: Rationale and Design for the STOp Recurrence of MMA Bleeding (STORMM) Randomized-Control Trial

Brief 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).

Detailed Description

Evidence to support the benefit of MMA embolization remains limited and the risk-benefit balance remains unclear. Case series have shown that recurrence rates with embolization are much lower, and that embolization is generally very safe. Risks associated with neurointerventional procedures will be directly discussed with patients or their caretakers as part of the conventional consenting procedure. Risks include access site hematoma, radiation exposure, vascular injury, brain ischemia, death (theoretic and extremely unlikely) and typical risks associated with general or local anaesthesia. The potential efficacy of MMA embolization as a treatment therefore requires higher level evidence in the form of randomized control trials.

The benefit of the embolization is a substantial reduction in recurrence of cSDH, which has been reported to be as high 1 in 3-4 patients. Recurrence of cSDH can lead to additional surgery and complications.

First objective: Evaluate the recurrence rates of cSDH after combined surgical and MMA embolization treatments (Arm 2) versus surgery alone (Arms 1).

Second objective: The second objective is to evaluate the stability and regression of cSDH after for all the Arms of the study at follow-up.

• Chronic Subdural Hematomas
• Cerebral Compression Due to Injury

• MMA embolization

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, GenevaOTHER

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