NCT06825897

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,039 (estimated)
• Sponsor: Santiago Ortega Gutierrez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Advanced imaging and treatment decisions are made immediately, potentially speeding up treatment. Conventional evaluation in the emergency department (ED) - In this approach, patients undergo initial evaluation and imaging in the ED before being transferred to the neurointerventional suite if they are eligible for MT. The main goal of this study is to determine if bypassing the ED and directly transferring patients to the neurointerventional suite leads to better recovery and reduced disability at 90 days compared to the conventional strategy. Researchers will also assess other important outcomes, including safety (such as the risk of brain bleeding), quality of life after the stroke, efficiency of stroke care, and the use of healthcare resources (such as hospital stay length). The study will include approximately 2,039 adult patients aged 18 and older who are suspected of having an LVO stroke. To participate, patients must arrive at one of the participating thrombectomy-capable stroke centers within 7 hours of symptom onset. These centers are equipped to perform advanced stroke care, including MT. Participants in the trial will represent a diverse population reflective of the general community affected by stroke. The trial will take place at 20 hospitals across the United States, all with high experience in treating stroke patients. The study will help provide critical insights into which triage strategy offers the best outcomes for patients with LVO strokes and improve future care for these emergencies.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
OTHER	Conventional Triage for Mechanical Thrombectomy	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.
OTHER	Direct Transfer to Angiography Suite (DTAS	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.

Timeline

• Start date: 2026-01-27
• Primary completion: 2028-04-30
• Completion: 2028-04-30
• First posted: 2025-02-13
• Last updated: 2026-03-13

Locations

6 sites across 1 country: United States