Emergency Stroke Unit With NeuAngio-CT (ESU-ACT) (NCT07456228) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Emergency Stroke Unit With NeuAngio-CT (ESU-ACT)
China500 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years;
✓. Clinically diagnosed with acute ischemic stroke;
✓. RACE score ≥ 4 points upon hospital arrival;
✓. Time from symptom onset/last known normal to hospital arrival ≤ 6 hours;
✓. Pre-stroke mRS score 0-1;
✓. Informed consent signed by the patient or their legal representative.
Exclusion criteria
✕. Hemorrhagic stroke diagnosed by cranial CT or MRI during this current episode;
✕. Uncontrolled hypertension with medication (defined as systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg) (Note: Patients may be included if blood pressure can be successfully reduced and maintained at an acceptable level with medication);
✕. Known hereditary or acquired bleeding tendency, such as coagulation factor deficiency, or INR \> 3.0 or PT \> 3 times the normal range after anticoagulant therapy (Patients without a history of coagulation dysfunction or suspected coagulation dysfunction do not need to wait for laboratory results of INR or prothrombin time before enrollment);
What they're measuring
1
Proportion of patients with mRS score 0-2 at 90 days
✕. Received heparin, low-molecular-weight heparin (e.g., dalteparin sodium), or thrombin inhibitors (e.g., bivalirudin, argatroban) within 24 hours with a history of coagulation disorders;
✕. Patients with renal failure, defined as serum creatinine \> 3.0 mg/dl (264 μmol/l) (Note: Patients undergoing dialysis can be included regardless of serum creatinine level);
✕. Cerebral embolism caused by septic emboli or bacterial endocarditis;