Direct transfer to the angiography suite versus emergency department evaluation for suspected large vessel occlusion stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic randomized trial compares two triage strategies for adults with suspected large vessel occlusion (LVO) stroke presenting within 7 hours of last known well: direct transfer to the neurointerventional angiography suite (DTAS) versus conventional emergency department (ED) evaluation before transfer. Patients meeting severity and timing criteria are randomized to either immediate angio-suite workup and possible mechanical thrombectomy or the standard ED imaging and assessment pathway. The primary outcome is functional recovery and disability at 90 days, and secondary outcomes include safety measures such as hemorrhage, quality of life, and time metrics. The trial includes both direct arrivals and interfacility transfers with specific timing rules for eligible participants.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Memorial Healthcare System
  Hollywood, Florida, United States Recruiting
• University of Miami/ Jackson Memorial Hospital
  Miami, Florida, United States Recruiting
• University of Michigan Health-West
  Wyoming, Michigan, United States Recruiting
• Saint Louis University
  St Louis, Missouri, United States Recruiting
• Cooper University Hospital
  Camden, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Santiago Ortega, MD — University of Iowa
• Study coordinator: Santiago Ortega, MD
• Email: santy-ortega@uiowa.edu
• Phone: 319-384-5628

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.