Matched microcatheter and guidewire use for middle meningeal artery embolization in chronic subdural hematoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center observational project compares outcomes when middle meningeal artery embolization for chronic subdural hematoma is performed using a matched Aristotle 14 guidewire and Plato 17 microcatheter versus devices chosen by the treating surgeon. Participants are assigned with a 50/50 chance to either the matched-device group or the surgeon-preference group, and the embolization procedure and follow-up occur as part of standard clinical care. The study records procedural performance, device function, and clinical outcomes without requiring extra visits beyond routine care. Collected data will be analyzed to determine whether the matched device pairing offers procedural advantages or improved patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years old
* Patient or legally authorized representative (LAR) signs an informed consent form
* Confirmed diagnosis of subacute or chronic subdural hematoma, defined as 50% or more chronic blood
* Pre-morbid Modified Rankin Score of ≤ 3

Exclusion Criteria:

* Age \< 18 years old
* Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization
* Unmanaged, uncontrolled bleeding disorders/blood diathesis
* Presumed septic embolus, or suspicion of microbial superinfection
* Contraindication to angiography
* CT or MRI evidence of intra-cranial tumor or mass lesion

Where it's running

• The Ohio State University Wexner Medical Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Edouard Belizaire
• Email: edouard.belizaire@osumc.edu
• Phone: 614.366.6936

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.