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Coil treatment may prevent brain bleed recurrence

NCT ID NCT07291427

Disease control Sponsor: Icahn School of Medicine at Mount Sinai 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tests whether using special coils to block blood vessels can help treat chronic subdural hematoma, a type of brain bleed common in older adults. Researchers will enroll 150 people to see if the procedure reduces bleeding and prevents the need for repeat surgery. The approach is already used in some cases, but this trial aims to confirm its safety and effectiveness.

What this could mean

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

Active substance
Balt coils (detachable coils used to block blood vessels)
What this could lead to
If successful, this could offer a less invasive way to prevent chronic subdural hematomas from coming back after treatment.
What could go wrong
This is an early-stage registry study, not a randomized trial. The device may not reduce recurrence, and risks include stroke or other complications.

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 150 people

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

Started

Jun 2026

Expected to finish

Sep 2028

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 with symptomatic chronic subdural hematoma (cSDH), with or without previous surgical evacuation that need additional treatment

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 * Patients experiencing unilateral or bilateral non-acute subdural hematoma confirmed by CT imaging. Acute on Chronic or mixed density hematoma allowed. * A clinical decision has been made to use coiling and/or embolics as treatment, with or without surgical debridement, independently as per standard of care and prior to enrollment in the study. * Signed informed consent obtained by patient or Legal Authorized Representative (LAR) Exclusion criteria: * Primary acute SDH * Prior MMAE in target territory * Premorbid mRS \> 3 * Common carotid stenosis \>70% or prior carotid stent placement * Significant medical contraindication to angiography (kidney failure/disease) * Anatomical variations that would make MMA embolization difficult or unsafe * Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints * Pregnancy * Life expectancy ≤ 1 year

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural Hematoma, Subdural, Chronic

As listed by the trial registrant

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

Chronic subdural hemorrhage (CSDH)

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

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

More trials for these conditions

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