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RECRUITING
NCT07324551

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

Sponsor: Ohio State University

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-11-03

Completion Date

2029-07-01

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DEVICE

Matched 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.

DEVICE

Surgeon combination preference

Surgeon will decide the on guidewire and microcatheter to use for MMA embolization

Locations (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States