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

NCT07670065 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: KY2026-102-02
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke; Large Vessel Occlusion

Keywords

Sliding CT/DSA; One-stop Management; Mechanical Thrombectomy; Emergency Stroke Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

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

EXPERIMENTAL

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

Conventional Thrombectomy

PLACEBO COMPARATOR

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

Interventions

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

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.

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

Conventional Thrombectomy DEVICE

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.

Conventional Thrombectomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zeguang Ren, Dr.

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Central Study Contacts

Yongjun Wang, Dr.

CONTACT

59978555; yongjunwang@ncrcnd.org.cn

Xuewei Xie, Dr.

CONTACT

59978555; xueweixie@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 26, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)