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New microcatheter aims to improve brain bleed treatment

NCT ID NCT07324551

Disease control Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new microcatheter device (Aristotle 14 guidewire and Plato 17 microcatheter) for treating chronic subdural hematoma, a type of brain bleed. About 100 adults will be randomly assigned to receive the new device or the surgeon's usual choice. Researchers will compare procedure time, success of blocking the bleeding artery, and rates of bleeding recurrence at 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aristotle 14 guidewire and Plato 17 microcatheter
What this could lead to
If successful, this device could become a preferred tool for treating chronic subdural hematoma, potentially reducing procedure time and bleeding recurrence.
What could go wrong
This is an early, single-center study with only 100 participants, so results may not apply broadly. The device may not outperform standard care, and there are risks of adverse events during surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients admitted to The Ohio State University Wexner Medical Center

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural, Chronic hemorrhagic stroke intracerebral hemorrhage Intracranial Hemorrhages

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic subdural hematoma Hemorrhage brain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.