Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit

Официальное название

Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit to Reduce Time to Endovascular Reperfusion for Acute Ischemic Stroke

Обзор

This study investigates whether direct transfer to an emergency stroke unit equipped with NeuAngio-CT reduces time to endovascular reperfusion in patients with acute ischemic stroke and suspected intracranial large-vessel occlusion.Those aged 18-60 years with acute ischemic stroke who are eligible for endovascular thrombectomy within 24 hours of symptom onset will be enrolled. Participants will be randomly assigned to one of two groups. In the intervention group, participants will undergo femoral or radial artery puncture, followed by intracranial and cervical CT angiography with intra-arterial contrast injection (iacCTA) performed using the sliding-rail NeuAngio-CT, and subsequent thrombectomy guided by fused CTA-DSA images. In the control group, participants will receive intracranial and cervical CT angiography with intra-venous contrast injection and the thrombectomy will guided by standard DSA imaging without use of the sliding-rail CT. The primary endpoint is puncture-to-successful-reperfusion time (PRT); if successful reperfusion is not achieved, the end-of-procedure time will be used.

Подробное описание

Timely reperfusion is critical for acute ischemic stroke. Current workflows require participants to undergo intracranial and cervical CTA in a CT suite before transfer to the catheterization laboratory, which adds significant delays. Furthermore, conventional intracranial and cervical CTA has limited sensitivity for detecting medium vessel occlusions due to venous contamination and calcification artifacts. We established an emergency stroke unit with NeuAngio-CT, which is sited within the emergency department and integrates clinical assessment, brain imaging, and initial treatment for patients with suspected stroke. It optimizes the thrombectomy workflow by providing a onestop, multimodal diagnostic and therapeutic solution that eliminates patient transfers between CT and the angiography suite. The system enables rapid switching and integration between CT and digital subtraction angiography (DSA) with real-time acquisition and fusion of CT and DSA datasets, yielding more comprehensive and accurate imaging information to support treatment decisions.This is a multicenter, open-label, randomized, parallel-controlled, non-inferiority trial. Those aged 18-60 years with acute ischemic stroke who are eligible for endovascular thrombectomy within 24 hours of symptom onset will be enrolled. Participants must have completed a venous head and neck CTA confirming a treatable vessel occlusion. They will be randomly assigned in a 1:1 ratio to the experimental group or the control group.In the intervention group, participants will undergo femoral or radial artery puncture, followed by intracranial and cervical CT angiography with intra-arterial contrast injection (iacCTA) performed using the sliding-rail NeuAngio-CT, and subsequent thrombectomy guided by fused CTA-DSA images. In the control group, participants will receive intracranial and cervical CT angiography with intra-venous contrast injection and the thrombectomy will guided by standard DSA imaging without use of the sliding-rail CT. The primary endpoint is puncture-to-successful-reperfusion time (PRT); if successful reperfusion is not achieved, the end-of-procedure time will be used. Safety endpoints include total contrast agent volume, cumulative radiation dose, rate of serious surgical complications within 7 days or before discharge, and incidence of adverse events and serious adverse events. All participants will be assessed on the day of enrollment and at postoperative day 7 or hospital discharge.

Вмешательства

• Устройство Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit
  Participants will undergo femoral or radial artery puncture, followed by intracranial and cervical CT angiography with intra-arterial contrast injection (iacCTA) performed using the sliding-rail NeuAngio-CT, and subsequent thrombectomy guided by fused CTA-DSA images.
• Устройство Conventional Thrombectomy
  Participants will receive intracranial and cervical CT angiography with intra-venous contrast injection and the thrombectomy will guided by standard DSA imaging without use of the sliding-rail CT.

Первичные конечные точки

• Puncture-to-reperfusion time (PRT) [Срок оценки: immediately after the intervention]

Вторичные конечные точки (8)

• Intervention-to-reperfusion time (IRT) [Срок оценки: immediately after the intervention]
• Procedure duration [Срок оценки: immediately after the intervention]
• Puncture completion-to-first-recanalization time [Срок оценки: immediately after the intervention]
• First-pass recanalization rate [Срок оценки: immediately after the intervention]
• Contrast volume from puncture to end of procedure [Срок оценки: immediately after the intervention]
• Radiation dose from puncture to end of procedure [Срок оценки: immediately after the intervention]
• Rate of serious procedural complications at 7 days post-procedure or prior to discharge [Срок оценки: at 7 days or at discharge]
• Adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: at 7 days or at discharge]

Критерии участия

Критерии включения

• Age 18-60 years;
• Clinical diagnosis of acute ischemic stroke eligible for immediate endovascular treatment;
• Time from symptom onset or last known well ≤ 24 hours;
• Intravenous intracranial and cervical CT angiography completed;
• Confirmed target vessel occlusion amenable to endovascular intervention based on intravenous intracranial and cervical CT angiography findings;
• Written informed consent obtained from the patient or their legally authorized representative.

Критерии исключения

• Known contrast agent allergy;
• Renal insufficiency with GFR (glomerular filtration rate) < 45 mL/min/1.73 m²;
• History of kidney transplantation;
• Concomitant diabetes mellitus with current use of metformin;
• Women who are pregnant, breastfeeding, or have a positive pregnancy test at admission;
• Refractory hypertension (defined as systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) (Note: patients may be enrolled if blood pressure is successfully reduced and maintained at an acceptable level with antihypertensive therapy);
• Intracranial space-occupying lesion or other conditions deemed unsuitable for endovascular intervention on imaging;
• Any other serious comorbidity or complication that may interfere with study conduct or evaluation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT07670065 · KY2026-102-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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