Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center
Ohio State University
100 participants
Nov 3, 2025
OBSERVATIONAL
Conditions
Summary
The purpose of this study is to evaluate the function of matched pair Aristotle 14 Guidewire and Plato Microcatheter in MMA embolization treatment for chronic subdural hematoma compared to surgeon's preference
Eligibility
Inclusion Criteria4
- 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 Criteria6
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants will be randomized in 1:1 ratio to either use of study devices (matched pair Aristotle and Plato) or standard of care (surgeon combination preference) using block randomization method with a fixed block size of 4 ensuring 50% will be randomized to study devices group and 50% randomized to standard of care group.
Surgeon will decide the on guidewire and microcatheter to use for MMA embolization
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07324551