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Brain bleed breakthrough? new study tests artery blocking to avoid surgery

NCT ID NCT04402632

Disease control Sponsor: Medtronic Neurovascular Clinical Affairs Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a procedure that blocks a blood vessel in the brain to treat subdural hematoma, a type of brain bleed. Instead of standard surgery, doctors used a liquid material called Onyx to seal the artery. The trial involved 600 people with subacute or chronic subdural hematoma to see if this approach is safe and effective.

What this could mean

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

Active substance
Onyx liquid embolic system
What this could lead to
If it works, this could offer a less invasive treatment for subdural hematoma, potentially reducing the need for brain surgery and improving recovery.
What could go wrong
This is a completed trial, but results are not yet widely available. The procedure carries risks like bleeding or stroke, and it may not work for everyone.

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

600 people

The number who actually took part.

Started

Oct 2020

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 90 years

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: * Pre-morbid Modified Rankin Score ≤3 * Confirmed diagnosis of subacute or chronic subdural hematoma * Completed informed consent * Meets criteria for Surgery or Observation Cohort Exclusion Criteria: * Life expectancy \<1 year * Unable to complete follow-up * Pregnant, lactating, or has a positive pregnancy test at time of admission * Diagnosed with acute SDH * Potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolization * Pre-randomized Markwalder Grading Scale score ≥ 3 * Unmanaged, uncontrolled bleeding disorders/blood diathesis * Presumed septic embolus, or suspicion of microbial superinfection * Known active COVID-19 infection * CT or MRI evidence of intra-cranial tumor or mass lesion Contraindication to angiography * Participation in another clinical trial * Contraindicated for the use of Onyx™ LES * Cannot be taken off corticosteroids (intended to treat subacute or chronic SDH) for at least 90 days post-randomization

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural

As listed by the trial registrant

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

Subdural hematoma

Contacts and locations

Locations

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068, United States

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Ascension Saint Vincent Hospital

    Indianapolis, Indiana, 46260, United States

  • Atrium Health's Carolinas Medical Center

    Charlotte, North Carolina, 28204, United States

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 322047, United States

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Baylor Scott & White Medical Center - Temple

    Temple, Texas, 76508-0001, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Buffalo General Medical Center

    Buffalo, New York, 14203, United States

  • California Pacific Medical Center

    San Francisco, California, 94109, United States

  • Carondelet St. Joseph's Hospital

    Tucson, Arizona, 85710, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195-0001, United States

  • Corewell Health

    Grand Rapids, Michigan, 49503, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303, United States

  • Harborview Medical Center

    Seattle, Washington, 98104-2420, United States

  • Huntington Memorial Hospital

    Pasadena, California, 91105, United States

  • Jackson Memorial Hospital

    Miami, Florida, 33136, United States

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805-0001, United States

  • McLaren Flint Hospital

    Flint, Michigan, 48532, United States

  • Memorial Hermann-Texas Medical Center

    Houston, Texas, 77030, United States

  • Memorial Regional Hospital

    Hollywood, Florida, 33021, United States

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10065, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104, United States

  • Oregon Health & Science University Hospital

    Portland, Oregon, 97239-3011, United States

  • Orlando Regional Medical Center Orlando Health

    Orlando, Florida, 32806, United States

  • Prisma Health

    Greenville, South Carolina, 29605, United States

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606, United States

  • Providence Little Company of Mary Medical Center

    Torrance, California, 90503-4607, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Saint Mary's Medical Center

    West Palm Beach, Florida, 33407, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The Mount Sinai Hospital

    New York, New York, 10029, United States

  • The Ohio State University/Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • UCSD Medical Center

    San Diego, California, 92037, United States

  • UF Health Heart and Vascular Hospital

    Gainesville, Florida, 32608, United States

  • USC - Keck School of Medicine

    Los Angeles, California, 90033, United States

  • University of Alabama at Birmingham (UAB) Hospital

    Birmingham, Alabama, 35233-1932, United States

  • University of California Irvine Medical Center

    Irvine, California, 92868, United States

  • University of California San Francisco Medical Center

    San Francisco, California, 94143, United States

  • University of Colorado Denver School of Medicine

    Aurora, Colorado, 80045, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kentucky Albert B Chandler Hospital

    Lexington, Kentucky, 40506, United States

  • University of Pittsburgh Medical Center UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213-2536, United States

  • University of Utah Hospital

    Salt Lake City, Utah, 84132, United States

  • Valley Baptist Medical Center

    Harlingen, Texas, 78550, United States

  • Westchester Medical Center

    Valhalla, New York, 10595, United States

More trials for these conditions

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