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

NCT07324551 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-01-07

No results posted yet for this study

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

Conditions

  • Chronic Subdural Hematoma
  • Hemorrhage Brain

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

Sponsors & Collaborators

  • Scientia Vascular, Inc.

    collaborator UNKNOWN

  • Ohio State University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2028-07-01
Completion
2029-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07324551 on ClinicalTrials.gov