Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center
Ohio State University
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
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceMatched pair Aristotle 14 guidewire and Plato 17 microcatheter
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.
- DeviceSurgeon combination preference
Surgeon will decide the on guidewire and microcatheter to use for MMA embolization
Location
- The Ohio State University Wexner Medical CenterColumbus, Ohio