Matched microcatheter and guidewire use for middle meningeal artery embolization in chronic subdural hematoma
Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center
This will test whether using a matched Aristotle 14 guidewire and Plato 17 microcatheter during middle meningeal artery embolization works better than surgeons' usual device choices for adults with chronic subdural hematoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07324551 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with a confirmed subacute or chronic subdural hematoma (≥50% chronic blood) and a pre-morbid Modified Rankin Score of ≤3 who can consent or have a legally authorized representative are ideal candidates.
Not a fit: Patients under 18, those with dangerous vascular anatomy for access, unmanaged bleeding disorders, suspected septic embolus or intracranial tumor, or any contraindication to angiography are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the matched guidewire and microcatheter could make the embolization procedure easier or safer and may reduce recurrence or complications of chronic subdural hematoma.
How similar studies have performed: Middle meningeal artery embolization for chronic subdural hematoma has shown favorable results in other studies, but the specific matched Aristotle/Plato device pairing is an early, single-center experience.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Columbus, Ohio
- 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
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.