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

21 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

232

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

      • Beijing, Cina
        • Beijing Tiantan Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Puncture-to-reperfusion time (PRT)
Lasso di tempo: 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

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Zeguang Ren, Dr., Beijing Tiantan Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

8 giugno 2026

Completamento primario (Stimato)

15 agosto 2027

Completamento dello studio (Stimato)

15 ottobre 2027

Date di iscrizione allo studio

Primo inviato

24 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 giugno 2026

Primo Inserito (Effettivo)

26 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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