RecruitingNot Applicable

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

United States100 participantsStarted 2025-11-03

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 or MRI evidence of intra-cranial tumor or mass lesion

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Navigation/procedure time

Timeframe: 2 years

Final Embolization Grades

Timeframe: 2 Years

Incidence of AE at time of surgery

Timeframe: 2 Years

Incidence of recurrence of hemorrhage

Timeframe: 2 Years

Trial details

NCT IDNCT07324551

SponsorOhio State University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-07-01

Contact for this trial

Edouard Belizaire

614.366.6936 edouard.belizaire@osumc.edu

View on ClinicalTrials.gov More Chronic Subdural Hematoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.