- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07670065
Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit
21. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
232
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Yongjun Wang, Dr.
- Telefonnummer: 59978555
- E-Mail: yongjunwang@ncrcnd.org.cn
Studieren Sie die Kontaktsicherung
- Name: Xuewei Xie, Dr.
- Telefonnummer: 59978555
- E-Mail: xueweixie@163.com
Studienorte
-
-
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Beijing, China
- Beijing Tiantan Hospital
-
Kontakt:
- Xuewei Xie, Dr.
- Telefonnummer: 59978555
- E-Mail: xueweixie@163.com
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Placebo-Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Puncture-to-reperfusion time (PRT)
Zeitfenster: immediately after the intervention
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Time from puncture completion to successful recanalization; if recanalization is not achieved, the end of procedure is used instead.
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immediately after the intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Intervention-to-reperfusion time (IRT)
Zeitfenster: immediately after the intervention
|
immediately after the intervention
|
|
Procedure duration
Zeitfenster: immediately after the intervention
|
immediately after the intervention
|
|
Puncture completion-to-first-recanalization time
Zeitfenster: immediately after the intervention
|
immediately after the intervention
|
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First-pass recanalization rate
Zeitfenster: immediately after the intervention
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immediately after the intervention
|
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Contrast volume from puncture to end of procedure
Zeitfenster: immediately after the intervention
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immediately after the intervention
|
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Radiation dose from puncture to end of procedure
Zeitfenster: immediately after the intervention
|
immediately after the intervention
|
|
Rate of serious procedural complications at 7 days post-procedure or prior to discharge
Zeitfenster: at 7 days or at discharge
|
at 7 days or at discharge
|
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Adverse events (AEs) and serious adverse events (SAEs)
Zeitfenster: at 7 days or at discharge
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at 7 days or at discharge
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Zeguang Ren, Dr., Beijing Tiantan Hospital
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
8. Juni 2026
Primärer Abschluss (Geschätzt)
15. August 2027
Studienabschluss (Geschätzt)
15. Oktober 2027
Studienanmeldedaten
Zuerst eingereicht
24. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. Juni 2026
Zuerst gepostet (Tatsächlich)
26. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
26. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KY2026-102-02
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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