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

Delay Avoiding Primary Evaluation for Thrombectomy for Acute Stroke Patients With Large Vessel Occlusion in the Angiography Suite (DIRECT) Trial

This trial will see if taking adults with suspected large vessel occlusion stroke directly to the angiography suite instead of first evaluating them in the emergency department helps people recover better when they arrive within 7 hours of symptom onset.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2039 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Iowa (Academic / other)
• Locations: 6 sites (Iowa City, Iowa and 5 other locations)
• Trial ID: NCT06825897 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older who present to a participating thrombectomy-capable center with signs suggestive of LVO stroke, a baseline NIHSS ≥ 10, and arrival within 7 hours of last known well are the ideal candidates.

Not a fit: Patients who arrive outside the 7-hour window, have low stroke severity, or who do not meet imaging or transfer timing criteria are unlikely to benefit from the direct-to-angio approach in this trial.

Why it matters

Potential benefit: If successful, bypassing the ED and going straight to the angiography suite could shorten time to treatment and improve recovery and independence after severe LVO stroke.

How similar studies have performed: Some observational studies and a few randomized trials have suggested faster door-to-puncture workflows can improve outcomes, but randomized evidence for routine direct-to-angio routing remains limited and mixed.

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 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 this trial is running

Iowa City, Iowa and 5 other locations

• University of Iowa — Iowa City, Iowa, United States (Not_yet_recruiting)
• Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
• University of Michigan Health-West — Wyoming, Michigan, United States (Recruiting)
• HMH Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
• The Research Foundation for SUNY on behalf of University at Buffalo — New York, New York, United States (Recruiting)
• The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Santiago Ortega, MD — University of Iowa
• Study coordinator: Santiago Ortega, MD

Conditions Stroke, Acute; Large Vessel Occlusion; Acute Ischemic Stroke; Pragmatic Clinical Trial