CompletedNot Applicable

Embolization of the Middle Meningeal Artery With ONYX™ Liquid Embolic System for Subacute and Chronic Subdural Hematoma

United States600 participantsStarted 2020-10-27

Plain-language summary

The purpose of this study is to evaluate the safety and efficacy of embolization of the middle meningeal artery (MMA) using the Onyx™ Liquid Embolic System (LES) for treatment of symptomatic subacute or chronic subdural hematoma (SDH)

Who can participate

Age range

18 Years – 90 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: * 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

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

Rate of hematoma recurrence/progression requiring surgical drainage OR poor clinical outcome at 90 days, OR clinical deterioration at 90 days compared to baseline

Timeframe: 90 days post-procedure

Trial details

NCT IDNCT04402632

SponsorMedtronic Neurovascular Clinical Affairs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-19

View on ClinicalTrials.gov More Subdural Hematoma trials

Who can participate

Age range

18 Years – 90 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.