Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07324551
Status
Recruiting
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Conditions

  • Chronic Subdural Hematoma
  • Hemorrhage Brain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Matched pair Aristotle 14 guidewire and Plato 17 microcatheter — DEVICE
    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 combination preference — DEVICE
    Surgeon will decide the on guidewire and microcatheter to use for MMA embolization

Study Details

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

Key Dates

Start date
Nov 3, 2025
Status verified
Nov 2025
Primary completion
Jul 1, 2028
Completion
Jul 1, 2029

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Total Navigation/procedure time [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical CenterColumbusOhio43210
Edouard J Belizaire, BA
[email protected]
614-366-6936
6143666936

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By research site
The Ohio State University Wexner Medical Center· Columbus, OH

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