Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Delay Avoiding Primary Evaluation for Thrombectomy for Acute Stroke Patients With Large Vessel Occlusion in the Angiography Suite (DIRECT) Trial
Who can join
Ages 18 and older · All sexes
Full 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.
About the 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.
What is being tested
- Conventional Triage for Mechanical Thrombectomy (other)
- Direct Transfer to Angiography Suite (DTAS (other)
Sponsor: Santiago Ortega Gutierrez · Participants: 2,039 · Started: Jan 27, 2026
Contact the study team
- Santiago Ortega, MD · Phone: 319-384-5628
- Carlos A Contreras Mesa, MSc · Phone: 3194992748
Official record on ClinicalTrials.gov — NCT06825897
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.