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- Essai clinique NCT07670065
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
Statut
Pas encore de recrutement
Les conditions
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
- Nom: Yongjun Wang, Dr.
- Numéro de téléphone: 59978555
- E-mail: yongjunwang@ncrcnd.org.cn
Sauvegarde des contacts de l'étude
- Nom: Xuewei Xie, Dr.
- Numéro de téléphone: 59978555
- E-mail: xueweixie@163.com
Lieux d'étude
-
-
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Beijing, Chine
- Beijing Tiantan Hospital
-
Contact:
- Xuewei Xie, Dr.
- Numéro de téléphone: 59978555
- E-mail: xueweixie@163.com
-
-
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
- 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.
Exclusion Criteria
- 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.
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.
Parrainer
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KY2026-102-02
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
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