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

ConditionsAcute Ischemic Stroke Large Vessel Occlusion

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-60

SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

232 Participants

are divided into 2 treatment groups

Group A: Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke UnitExperimental treatment 1 intervention

Group B: Conventional ThrombectomyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Puncture-to-reperfusion time (PRT)

Time from puncture completion to successful recanalization; if recanalization is not achieved, the end of procedure is used instead.

Time frame