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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke; Large Vessel Occlusion
• Intervention / Treatment: Device: Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit; Device: Conventional Thrombectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 232
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yongjun Wang, Dr.; Phone Number: 59978555; Email: yongjunwang@ncrcnd.org.cn
• Study Contact Backup: Name: Xuewei Xie, Dr.; Phone Number: 59978555; Email: xueweixie@163.com

Study Locations

• China
  • Beijing, China
    • Beijing Tiantan Hospital
    • Contact: Xuewei Xie, Dr.; Phone Number: 59978555; Email: xueweixie@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

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

Exclusion Criteria

1. Known contrast agent allergy;
2. Renal insufficiency with GFR (glomerular filtration rate) < 45 mL/min/1.73 m²;
3. History of kidney transplantation;
4. Concomitant diabetes mellitus with current use of metformin;
5. Women who are pregnant, breastfeeding, or have a positive pregnancy test at admission;
6. 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);
7. Intracranial space-occupying lesion or other conditions deemed unsuitable for endovascular intervention on imaging;
8. Any other serious comorbidity or complication that may interfere with study conduct or evaluation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puncture-to-reperfusion time (PRT)	Time from puncture completion to successful recanalization; if recanalization is not achieved, the end of procedure is used instead.	immediately after the intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Study Director: Zeguang Ren, Dr., Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 8, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): October 15, 2027

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: June 21, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Mechanical Thrombectomy; Sliding CT/DSA; One-stop Management; Emergency Stroke Care
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: KY2026-102-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No