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Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe

Sponsored by Santiago Ortega Gutierrez

About this study

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.

Large vessel occlusion (LVO) strokes are among the most severe types of strokes, caused by a blockage in one of the brain's major blood vessels. These strokes can lead to significant disability or death without prompt treatment. Mechanical thrombectomy (MT), a procedure that physically removes the clot, is one of the most effective treatments for LVO strokes. However, there is still uncertainty about the best way to quickly triage and prepare patients for MT to achieve the best outcomes. This study, called the DIRECT trial, aims to compare two common triage strategies for patients suspected of having an LVO stroke: Direct transfer to the neurointerventional angiography suite - In this strategy, patients are taken straight to the neurointerventional suite upon arrival at the hospital. Adv…

Where this study is enrolling (6)

Show all 6 locations

  • The University of Texas Health Science Center at Houston

    Houston, Texas

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Who can participate

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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Trial data sourced from ClinicalTrials.gov.