Stroke care showdown: direct to treatment vs. emergency room first
NCT ID NCT06825897
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether taking stroke patients straight to the angiography suite for clot removal, instead of first evaluating them in the emergency department, leads to better recovery. About 2,000 adults with severe stroke symptoms within 7 hours will be randomly assigned to one of the two approaches. The goal is to see if skipping the ER reduces disability and improves outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Direct transfer to angiography suite (procedure)
- What this could lead to
- If this works, it could show that sending stroke patients straight to the treatment room speeds up care and leads to better recovery with less disability.
- What could go wrong
- This is a large trial, but it's testing a process change, not a new drug. Results may vary across hospitals, and some patients might need emergency department evaluation that skipping could miss.
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
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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
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About 2,039 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: To be eligible for participation in the DIRECT trial, an individual must meet all of the following criteria: 1. Age: ≥ 18 years of age. 2. Clinical Presentation: Present to a participating TSC with signs or symptoms suggestive of acute LVO stroke. 3. Stroke Severity: Baseline NIHSS of 10 or higher. 4. Time since LKW: Time from LKW to arrival at the TSC must be within 7 hours. Additional criteria For all Interfacility Transfers: 1\. If imaging was performed at the outside facility, the time from the first imaging to arrival at the thrombectomy center must exceed 90 minutes. For all the Conventional Triage Arm, participants must also meet the following criteria: 1. Presence of a qualifying LVO by CTA or MRA imaging; or 2. For Large Core Patients: Patients with large core infarcts (CT-ASPECT score ≤ 5, DWI-ASPECT score ≤ 5, or infarct volume ≥ 70 cc) will be enrolled, irrespective of treatment decisions regarding embolectomy. For all DTAS Arm: 1\. Patients who do not have LVO occlusions in the angiography suite assessment (ICH, distal occlusions or mimics) will be enrolled, irrespective of treatment decisions regarding embolectomy. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in the trial: 1. Time Restrictions: Presentation to a thrombectomy-capable center more than 7 hours from LSW. 2. Imaging Criteria for Interfacility Transfer Patients: At sites enrolling transfer patients, any patient arriving from an outside hospital with time from imaging study at the presenting hospital to arrival at the TSC not exceeding 90 minutes. 3. Hemorrhagic Stroke: Presence of intracranial hemorrhage on brain imaging in the conventional strategy as Heidelberg that renders thrombectomy contraindicated.
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Conditions
The condition(s) this trial relates to.
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.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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HMH Hackensack University Medical Center
RECRUITINGHackensack, New Jersey, 07601, United States
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Henry Ford Health System
RECRUITINGDetroit, Michigan, 48202, United States
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The Research Foundation for SUNY on behalf of University at Buffalo
RECRUITINGNew York, New York, 14203, United States
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The University of Texas Health Science Center at Houston
RECRUITINGHouston, Texas, 77030, United States
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University of Iowa
NOT_YET_RECRUITINGIowa City, Iowa, 52242, United States
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University of Michigan Health-West
RECRUITINGWyoming, Michigan, 49519, United States
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- Can a robot unlock the Brain's recovery after stroke?