Endovascular Treatment for eXtra-Large Ischemic Stroke

Официальное название

Efficacy and Safety of Endovascular Thrombectomy Plus Medical Management Versus Medical Management Alone in Acute Ischemic Stroke Patients With Large Vessel Occlusion and Extra-Large Infarct Core: A Multicenter, Randomized Controlled Trial

Обзор

The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

Подробное описание

Several randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, six randomized controlled trials demonstrated the efficacy and safety of endovascular thrombectomy for large infarct patients (defined as Alberta Stroke Program Early Computed Tomography Score \[ASPECTS\] ≥3 or infarct core \<100ml). Patients with extra-large infarct core (volume greater than 100 mL, ASPECTS score of 0 to 2) accounted for a small proportion of these trials. Therefore, the role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. That is to say, exactly where the lower limit of endovascular thrombectomy is unknown. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

Вмешательства

• Препарат Medical management
  Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.
• Процедура Endovascular thrombectomy
  Endovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting.

Первичные конечные точки

• Modified Rankin Scale score [Срок оценки: 90 days after randomization]

Вторичные конечные точки (4)

• Rate of successful reperfusion [Срок оценки: Within 5 minutes at the end of angiogram]
• Rate of excellent outcome [Срок оценки: 90 days after randomization]
• Rate of functional independence [Срок оценки: 90 days after randomization]
• Rate of independent ambulation [Срок оценки: 90 days after randomization]

Критерии участия

Критерии включения

• Age 18 years or older, and modified Rankin scale score = 0 or 1 in patients 80 years or older;
• Acute ischemic stroke within 6 hours from last known well to randomization, or with negative MRI-FLAIR (no change on FLAIR sequence and presence of infarct on MRI-DWI) if > 6 hours or unknown last known well time;
• Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by CTA/MRA/DSA;
• Baseline ASPECTS score of 0-2 or infarct core volume ≥100ml;
• The patient or patient's representative signs a written informed consent form.

Критерии исключения

• CT or MR evidence of hemorrhage;
• Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
• Vessel tortuosity where it is expected that the thrombectomy device will not be able to reach the occlusion site or result in unstable access;
• History of bleeding disorders, severe heart, liver or kidney disease, or sepsis;
• Currently participating in another investigational drug study;
• Any terminal illness with life expectancy less than 6 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 · 2 центра

• The First Affiliated Hospital, Hengyang Medical School, University of South China — Hengyang
• Xiangtan Central Hospital — Xiangtan

Идентификаторы

NCT: NCT06388148 · XL STROKE-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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