NCT07324551Recruiting
Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center
Ohio State University
Start Date
11/3/2025
Completion Date
7/1/2029
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
Detailed Description
If you agree to take part, you will have a 50/50 chance of being assigned to one of two groups. In group 1, your procedure will use the study devices. In group 2, your procedure will use devices chosen by your surgeon. The procedure and follow up are part of standard medical care. This means that taking part in the study will not mean more time or energy compared to the usual treatment you would have.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DEVICE
Matched pair Aristotle 14 guidewire and Plato 17 microcatheter
DEVICE
Surgeon combination preference
Conditions
Chronic Subdural HematomaHemorrhage Brain
Locations
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United States