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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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

Первичные конечные точки

• The modified Rankin Scale (mRS) score 0-2 at 90 days [Срок оценки: 90 days]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing tiantan hospital — Пекин

Идентификаторы

NCT: NCT07460713 · 2024ZD0527605

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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