NCT07456228

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

Effect of Emergency Stroke Unit With NeuAngio-CT Direct for Acute Ischemic Stroke and Suspected Intracranial Large Vessel Occlusion (ESU-ACT)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study employs a multicenter, matched-cluster controlled design wherein 5 to 10 hospitals equipped with Neusoft Medical's domestic sliding-gantry Angio-CT/Digital Subtraction Angiography (ACT/DSA) system, and staffed by personnel who have completed standardized operational training, will be selected as the Exposure Group, while a corresponding 5 to 10 matched hospitals lacking this integrated system will serve as the Control Group. In the Exposure Group, the protocol dictates an optimized direct-to-angiography suite workflow; upon arrival, patients undergo immediate neurological evaluation utilizing the Rapid Arterial oCclusion Evaluation (RACE) scale and stat laboratory testing before being transferred directly to the angio suite. Intra-suite imaging is then acquired via the sliding-gantry system to perform non-contrast computed tomography (NCCT) and CT angiography (CTA). If a large vessel occlusion (LVO) is confirmed-specifically involving the M1/M2, P1, A1, or basilar artery (BA) segments-endovascular therapy (EVT), encompassing mechanical thrombectomy, balloon angioplasty, and/or stenting, is initiated immediately on the same table. For patients without an identified LVO, intravenous thrombolysis (IVT) is administered in situ if clinical eligibility is met. Conversely, patients in the Control Group will adhere to standard-of-care diagnostic pathways, undergoing initial cross-sectional neuroimaging (NCCT/CTA or MRI/MRA) in a conventional Radiology Department, where IVT is administered in accordance with current guidelines; if an LVO is radiologically confirmed during this standard workflow, patients are subsequently transferred to a separate angiography suite to undergo EVT.

Conditions

• Acute Ischemic Stroke

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: China