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

Recruiting now · Not applicable

Conditions studied: Stroke, Acute

In brief

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.

Key facts

Study ID

NCT06825897

Run by

Santiago Ortega Gutierrez

People needed

2039

Starts

2026-01-27

Expected to finish

2028-04-30

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible for participation in the DIRECT trial, an individual must meet all of the following criteria:
• Age: ≥ 18 years of age.
• Clinical Presentation: Present to a participating TSC with signs or symptoms suggestive of acute LVO stroke.
• Stroke Severity: Baseline NIHSS of 10 or higher.
• Time since LKW: Time from LKW to arrival at the TSC must be within 7 hours.
• Additional criteria
• For all Interfacility Transfers:
• 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:
• Presence of a qualifying LVO by CTA or MRA imaging; or
• 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:
• 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.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in the trial:
• Time Restrictions: Presentation to a thrombectomy-capable center more than 7 hours from LSW.
• 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.
• Hemorrhagic Stroke: Presence of intracranial hemorrhage on brain imaging in the conventional strategy as Heidelberg that renders thrombectomy contraindicated.

Where it is running

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

Full record on ClinicalTrials.gov

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