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Not Yet Recruiting NCT07670065

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

Conditions: Acute Ischemic Stroke, Large Vessel Occlusion

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 232
Sponsor: Beijing Tiantan Hospital

Location: Beijing Tiantan Hospital Beijing

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07670065). StuddyBuddy aggregates publicly available trial information.