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Not yet recruiting NCT07460713

Advancing Reperfusion Therapy for Ischemic Stroke: Direct Transfer to Angiography Suite for Patients With Suspected Large Vessel Occlusion

No phase Interventional Ischemic Stroke Large Vessel Occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: direct transfer to angiography suite, conventional CT/MRI triage strategy.
Who it may be relevant to
Registry conditions: Ischemic Stroke, Large Vessel Occlusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Direct Transfer to Angiography Suite (DTAS) for Patients With Suspected Large Vessel Occlusion

Overview

The investigators initiated a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of the direct transfer to angiography suite (DTAS) triage strategy compared to the conventional triage strategy with CT/MRI in patients with suspected large artery occlusive (LVO) within 6 hours of symptom onset.

Interventions

  • Procedure direct transfer to angiography suite
    Patients will bypass the emergency radiology imaging step and be directly transferred to the angiography suite. After screening for intracranial hemorrhage using flat-panel CT, intravenous tenecteplase will be administered according to current guidelines. DSA will be performed, and EVT will be provided for patients with confirmed LVO. EVT includes thrombectomy with stent retrievers, thromboaspiration, intra-arterial thrombolysis, balloon angioplasty, stenting, or a combination of these approache
  • Procedure conventional CT/MRI triage strategy
    Patients will undergo routine imaging, including non-contrast CT/CTA/CTP or MRI/MRA/PWI. For ischemic stroke patients, intravenous tenecteplase will be administered according to current guidelines. Patients with imaging-confirmed LVO will proceed to the angiography suite for further EVT following the standard procedure. EVT includes thrombectomy with stent retrievers, thromboaspiration, intra-arterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discre

Primary outcome measures

  • The modified Rankin Scale (mRS) score 0-2 at 90 days [Time frame: 90 days]
Secondary outcome measures (12)
  • Rates of endovascular treatment [Time frame: Immediately after the procedure]
  • Door-to-puncture time [Time frame: Immediately after the procedure]
  • Ordinal distribution of modified Rankin Scale (mRS) at 90 days [Time frame: 90 days]
  • The modified Rankin Scale (mRS) score of 0-1 at 90 days [Time frame: 90 days]
  • The proportion of successful recanalization [Time frame: Immediately after the procedure]
  • The rate of early neurological improvement at 24 hours [Time frame: 24 hours]
  • Symptomatic intracranial hemorrhage within 36 hours (as defined by SITS-MOST definition) [Time frame: 36 hours]
  • The proportion of all-cause mortality at 90 days [Time frame: 90 days]
  • The proportion of stroke-related mortality at 90 days [Time frame: 90 days]
  • The proportion of procedural complications [Time frame: Immediately after the procedure]
  • The proportion of serious adverse events (SAEs) [Time frame: 90 days]
  • Time to alternative treatment initiation in non-LVO patients [Time frame: Immediately after the intervention]

Eligibility criteria

Inclusion criteria

  • Age≥18 years old;
  • Patients presenting with symptoms or signs suggestive of acute large vessel occlusion (LVO) stroke；
  • Randomization within 6 hours of symptom onset；
  • Baseline NIHSS score ≥10 points prior to randomization;
  • Pre-stroke modified Rankin Scale (mRS) score ≤2;
  • Written informed consent from patients or their legally authorized representatives.

Exclusion criteria

  • Refusal of endovascular treatment；
  • Allergy to contrast agents;
  • Clinical symptoms or signs suggestive of intracranial hemorrhage (e.g., severe headache, seizures, or signs of increased intracranial pressure);
  • Transferred patients (e.g., from centers without thrombectomy capability);
  • Seizure at stroke onset, postictal paralysis, or inability or unwillingness to cooperate due to epilepsy or other neurological or psychiatric disorders;
  • Clinically unstable conditions requiring urgent life-support treatment;
  • Other standard contraindications to endovascular treatment;
  • Any terminal illness such that the patient would not be expected to survive more than 1 year;
  • Pregnant women, nursing mothers, or women with a positive pregnancy test at admission;
  • Unlikely to adhere to the trial protocol or follow-up;
  • Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study;
  • Participation in other interventional clinical trials within the previous 3 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing tiantan hospital — Beijing

Identifiers

NCT: NCT07460713 · 2024ZD0527605

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗