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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device 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.
• Device 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.

Primary outcome measures

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

Secondary outcome measures (8)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT07670065 · KY2026-102-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗