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

21 juin 2026 mis à jour par: Yongjun Wang, Beijing Tiantan Hospital

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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

232

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

      • Beijing, Chine
        • Beijing Tiantan Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
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.
Comparateur placebo: 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.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Puncture-to-reperfusion time (PRT)
Délai: immediately after the intervention
Time from puncture completion to successful recanalization; if recanalization is not achieved, the end of procedure is used instead.
immediately after the intervention

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Directeur d'études: Zeguang Ren, Dr., Beijing Tiantan Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

8 juin 2026

Achèvement primaire (Estimé)

15 août 2027

Achèvement de l'étude (Estimé)

15 octobre 2027

Dates d'inscription aux études

Première soumission

24 mai 2026

Première soumission répondant aux critères de contrôle qualité

21 juin 2026

Première publication (Réel)

26 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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