- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07670065
Direct Angio Suite Acute Stroke Intervention With CT/DSA Hybrid Emergency Stroke Unit
21. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
232
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Yongjun Wang, Dr.
- Telefonnummer: 59978555
- E-mail: yongjunwang@ncrcnd.org.cn
Undersøgelse Kontakt Backup
- Navn: Xuewei Xie, Dr.
- Telefonnummer: 59978555
- E-mail: xueweixie@163.com
Studiesteder
-
-
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Beijing, Kina
- Beijing Tiantan Hospital
-
Kontakt:
- Xuewei Xie, Dr.
- Telefonnummer: 59978555
- E-mail: xueweixie@163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Puncture-to-reperfusion time (PRT)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Intervention-to-reperfusion time (IRT)
Tidsramme: immediately after the intervention
|
immediately after the intervention
|
|
Procedure duration
Tidsramme: immediately after the intervention
|
immediately after the intervention
|
|
Puncture completion-to-first-recanalization time
Tidsramme: immediately after the intervention
|
immediately after the intervention
|
|
First-pass recanalization rate
Tidsramme: immediately after the intervention
|
immediately after the intervention
|
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Contrast volume from puncture to end of procedure
Tidsramme: immediately after the intervention
|
immediately after the intervention
|
|
Radiation dose from puncture to end of procedure
Tidsramme: immediately after the intervention
|
immediately after the intervention
|
|
Rate of serious procedural complications at 7 days post-procedure or prior to discharge
Tidsramme: at 7 days or at discharge
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at 7 days or at discharge
|
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Adverse events (AEs) and serious adverse events (SAEs)
Tidsramme: at 7 days or at discharge
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at 7 days or at discharge
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Zeguang Ren, Dr., Beijing Tiantan Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
8. juni 2026
Primær færdiggørelse (Anslået)
15. august 2027
Studieafslutning (Anslået)
15. oktober 2027
Datoer for studieregistrering
Først indsendt
24. maj 2026
Først indsendt, der opfyldte QC-kriterier
21. juni 2026
Først opslået (Faktiske)
26. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KY2026-102-02
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