Coil treatment showdown: one side or both for brain bleed?

NCT ID NCT07715656

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This trial tests whether blocking the blood supply to a chronic subdural hematoma (a slow brain bleed) on one side or both sides works better. Adults with a unilateral hematoma will receive either unilateral or bilateral coil embolization. The study measures changes in hematoma size and the need for additional surgery.

What this could mean

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

Active substance
coil embolization of the middle meningeal artery
What this could lead to
If successful, this could establish a standard approach for treating chronic subdural hematomas with fewer repeat surgeries.
What could go wrong
This is a mid-sized trial comparing two techniques; results may not show a clear advantage, and risks like bleeding or stroke remain.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

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

Started

Apr 2025

Expected to finish

Jun 2027

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.

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: Candidates for this study must meet ALL of the following criteria: 1. Subject is 18 years of age or older. 2. Subject has a diagnosis of chronic subdural hematoma with mass effect Determined by brain imaging (CT or MRI) and correlated clinical symptoms. 3. Pre-randomization modified Rankin Score (mRS) ≤3 a. Surgical Cohort: Assessment should reflect the subject's condition just prior to undergoing surgery. Assessment may be performed post-surgery using pre-surgical data. 4. Subdural Hematoma Size Medical Management Cohort: * Midline shift \< 10mm and hematoma thickness \> 10 mm as measured on coronal imaging perpendicular to the skull. * No focal deficit related to the chronic subdural hematoma requiring surgical intervention Surgical Cohort: • No requirement 5. A CT performed prior to randomization demonstrating stability of the hematoma. Stability is defined as no worsening of midline shift or increase in the size of the cSDH from the screening image that results in new or worsening clinical symptoms. 6. Patient or designated Legal Authorized Representative, confirms the patient has the mental capacity, willingness and ability to comply with protocol and follow-up requirements 7. In the opinion of the treating physician, MMA embolization is technically feasible, including evaluation of preoperative CTA, if available, or presence of a foramen spinosum bilaterally. Exclusion Criteria: * Candidates will be excluded from participation if ANY of the following apply: 1. Patients presenting with an acute SDH (e.g. patient with presenting with a SDH due to trauma); mixed density is permitted. 2. Subject presents with bilateral cSDHs requiring treatment (contralateral cSDH \<5mm and not requiring treatment is permitted. 3. Subject presents with Glasgow Coma Scale \< 9 4. Markwalder assessment \>4 5. cSDH that developed with underlying conditions such as vascular lesions, brain tumor, arachnoid cyst, spontaneous intracranial hypotension, end stage renal disease (ESRD) on hemodialysis, end stage liver disease or other comorbidities causing a coagulopathy 6. Prior carotid stent placement that crosses the origin of the External Carotid Artery (ECA) ipsilateral to the subdural hematoma 7. Presumed septic embolus, or suspicion of microbial superinfection 8. CT or MRI evidence of intra-cranial tumor or mass lesion 9. Significant contraindication to angiography (eg. kidney failure). 10. Life expectancy of less than 1-year 11. Women who are pregnant, lactating, plan on becoming pregnant during the course of the clinical investigation. We routinely do pregnancy tests prior to this procedure, to avoid radiation exposure to the fetus including radiation on follow up CT scans 12. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Subjects in observational, natural history, and/or epidemiological studies not involving intervention are eligible 13. Patient unwilling to follow SOC recommendations (e.g. refuses surgery or lifestyle modifications)

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural, Chronic

As listed by the trial registrant

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

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

  • Lahey Hospital & Medical Center

    RECRUITING

    Burlington, Massachusetts, 01803, United States

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