Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Matched pair Aristotle 14 guidewire and Plato 17 microcatheter
- Surgeon combination preference
Treatment groups
No treatment groups listed
Sponsors and collaborators
Ohio State University
Lead sponsor
Scientia Vascular, Inc.
Collaborator
Source ClinicalTrials.gov