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NCT07456228

Emergency Stroke Unit With NeuAngio-CT (ESU-ACT)

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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

Locations (1)

Beijing Tiantan Hospital

Beijing, China