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Emergency Stroke Unit With NeuAngio-CT (ESU-ACT)
Sponsor: Beijing Tiantan Hospital
Summary
Rationale: Acute ischemic stroke caused by large-vessel occlusion (LVO) requires rapid recanalization to minimize neurological damage, as shorter onset-to-reperfusion times are strongly associated with better clinical outcomes. Conventional management workflows, which involve separate non-contrast CT or multimodal imaging assessments prior to transfer to the angiography suite, often introduce significant delays. The implementation of a "one-stop" management model using a hybrid sliding-gantry CT/DSA suite allows for immediate diagnosis and subsequent intervention in a single clinical environment, potentially streamlining the transition to treatment. Therefore, the aim of this study is to demonstrate the superiority of the one-stop hybrid suite workflow compared to standard imaging-first management in improving functional outcomes for patients with suspected LVO presenting within 6 hours of symptom onset. Methods and Design: This study is a prospective, multicenter, matched cluster, open-label, blinded endpoint non-randomized cohort. It includes patients aged ≥18 years with a RACE score ≥4, a pre-stroke mRS score ≤1, and suspected intracranial LVO within 6 hours of onset. Hospitals in the exposure group utilize an Emergency Stroke Unit equipped with a sliding NeuAngio-CT/DSA hybrid suite, while control hospitals follow the conventional imaging workflow. Study Outcomes: The primary outcome is the proportion of patients achieving functional independence at 90 days, defined as a modified Rankin Scale (mRS) score of 0-2. The primary safety outcome is the proportion of patients with all-cause mortality at 7 days or at the time of hospital discharge.
Official title: Effect of Emergency Stroke Unit With NeuAngio-CT Direct for Acute Ischemic Stroke and Suspected Intracranial Large Vessel Occlusion (ESU-ACT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2026-03
Completion Date
2028-03
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Locations (1)
Beijing Tiantan Hospital
Beijing, China