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.
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.
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.
Crossover
Conventional Triage for Mechanical Thrombectomy
Other interventionParticipants 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.
Direct Transfer to Angiography Suite (DTAS
Other interventionPatients 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.
Global Disability at 90 Days
Global disability will be measured using the disability-weighted modified Rankin Scale (dw-mRS) at 90 days (±14 days) post-stroke. The dw-mRS is a validated tool assessing the severity of disability across seven levels, from no symptoms (0) to severe disability or death (6). This outcome evaluates whether the direct transfer to the angiography suite (DTAS) strategy results in improved functional outcomes compared to the conventional triage strategy.
Functional Independence at 90 Days
The proportion of patients achieving functional independence, measured by a dichotomized modified Rankin Scale score (mRS 0-2), assessed during the in-hospital stay and at 90 (±14) days after treatment.
Stroke Workflow Efficiency
Metrics include door-to-puncture times, door-to-reperfusion times, and rates of intravenous thrombolysis administration, evaluating the time taken to perform key steps in stroke workflow.
Procedural Success
Reperfusion rates of the large vessel occlusion (LVO) using the Extended Thrombolysis in Cerebral Ischemia (eTICI) scale, with successful reperfusion defined as mTICI 2b-3.
Cognitive Ability
Assessed at 90 days using the Montreal Cognitive Assessment (MoCA), measuring domains such as memory, attention, and executive function.
Global Disability
Disability measured by all seven ordinal levels of the modified Rankin Scale (mRS) at hospital discharge.
Instrumental Activities of Daily Living
Measured at 90 days using the Barthel Index, assessing the patient's ability to perform daily activities independently.
Caregiving Burden
Caregiving burden assessed using Zarit's Burden Interview (ZBI) at 90 days, evaluating the impact of stroke on caregivers.
Healthcare Utilization
Assessed by metrics such as length of hospital stay, home-time, and number of days spent at initial residency level within 90 days post-stroke.
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Santiago Ortega Gutierrez
Lead sponsor
University of Iowa
Sponsor institution
Patient-Centered Outcomes Research Institute
Collaborator
