No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
2,039 (estimated)
Sponsor
Santiago Ortega Gutierrez · Other
Who this trial is looking for
This trial is looking for adults with suspected acute stroke caused by a blockage in a large blood vessel. Participants will either go directly to a special imaging room or first be seen in the emergency department to find out which approach helps them recover better.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have signs of an acute stroke.
My stroke severity score is 10 or higher.
I arrived at the treatment center within 7 hours of my symptoms beginning.
You may not be able to join if
I arrived at the treatment center more than 7 hours after my symptoms started.
I had brain imaging done at another hospital and took less than 90 minutes to get to the treatment center.
I have bleeding in the brain that prevents treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to compare two strategies for treating adults with suspected large vessel occlusion stroke within 7 hours of symptom onset. Researchers will evaluate whether direct transfer to the neurointerventional angiography suite improves recovery and reduces disability compared to the conventional approach of first being evaluated in the emergency department. The study will also…
The purpose of this study is to compare two strategies for treating adults with suspected large vessel occlusion stroke within 7 hours of symptom onset. Researchers will evaluate whether direct transfer to the neurointerventional angiography suite improves recovery and reduces disability compared to the conventional approach of first being evaluated in the emergency department. The study will also assess safety and other health outcomes to guide care for stroke patients.
Trial Locations
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Eligibility Criteria
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 N…
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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