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
Santiago Ortega Gutierrez
2,039 participants
Jan 27, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria13
- 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.
Exclusion Criteria4
- 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.
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Interventions
Participants undergo the conventional standard-of-care triage process. Upon arrival at the thrombectomy-capable center, patients first undergo an initial evaluation in the emergency department (ED), which includes diagnostic imaging (CT or MRI) to confirm eligibility for mechanical thrombectomy (MT). If the patient is found to have a large vessel occlusion (LVO) suitable for thrombectomy, they are transferred to the neurointerventional suite for treatment.
Patients who arrive at the thrombectomy-capable center (from home, mobile stroke units, or interfacility transfer) are immediately transferred to the neurointerventional suite, bypassing the emergency department (ED). Upon arrival in the neurointerventional suite, initial neuroimaging (typically using flat panel CT or other imaging modalities) is conducted to confirm the presence of a large vessel occlusion (LVO). If the patient is eligible for mechanical thrombectomy (MT), treatment is initiated directly in the angiography suite. This approach aims to reduce delays in care and improve clinical outcomes by providing faster access to thrombectomy treatment.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06825897