Delay Avoiding Primary Evaluation for Thrombectomy for Acute Stroke Patients With Large Vessel Occlusion in the Angiography Suite (DIRECT) Trial
Santiago Ortega Gutierrez
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.
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 o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 minu…
Interventions
- OtherConventional 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.
- OtherDirect 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.
Locations (6)
- University of IowaIowa City, Iowa
- Henry Ford Health SystemDetroit, Michigan
- University of Michigan Health-WestWyoming, Michigan
- HMH Hackensack University Medical CenterHackensack, New Jersey
- The Research Foundation for SUNY on behalf of University at BuffaloNew York, New York
- The University of Texas Health Science Center at HoustonHouston, Texas