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Идёт набор NCT06210633

Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke

— Наблюдательное Acute Ischemic Stroke (AIS) Acute Ischemic Stroke From Large Vessel Occlusion

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: medical management, endovascular thrombectomy.
Кому может быть актуально
Состояния в реестре: Acute Ischemic Stroke (AIS), Acute Ischemic Stroke From Large Vessel Occlusion. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

XL STROKE: A Nationwide Prospective Registry of Endovascular Thrombectomy for Extra-large Ischemic Stroke With Large Vessel Occlusion

Обзор

Since 2015, many randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, five randomized controlled trials (ANGEL-ASPECT \[Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core\], LASTE \[LArge Stroke Therapy Evaluation\], RESCUE-Japan LIMIT \[The Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial\], SELECT 2 \[Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke\], and TENSION \[The Efficacy and Safety of Thrombectomy in Stroke with extended lesion and extended time window\]) demonstrated the efficacy and safety of 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 (ASPECTS score of 2 or less) were excluded from these trials. Therefore, the efficacy of endovascular thrombectomy in patients with extra-large ischemic burden has not been well studied. The XL STROKE registry is aiming to investigate the clinical outcomes and safety of mechanical thrombectomy in acute extra-large ischemic stroke.

Вмешательства

  • Другое medical management
    Medical management will be based on the recommendations of the stroke management guidelines of the Chinese Stroke Association. Patients will receive intravenous thrombolysis according to the guidelines if they are eligible for thrombolysis. Patients who are not treated with intravenous thrombolysis will be treated with aspirin, unless an indication for early anticoagulation is present.
  • Другое endovascular thrombectomy
    The use of devices (i.e. stent-retriever, aspiration catheter) is at the discretion of neurointerventionalist. Intra-arterial administration of alteplase, tenecteplase, tirofiban, angioplasty and stenting will also be permitted.

Первичные конечные точки

  • Modified Rankin Scale score [Срок оценки: 90±14 days after enrollment]
Вторичные конечные точки (12)
  • Independent ambulation [Срок оценки: 90±14 days after enrollment]
  • Not ambulatory nor capable of body self-care [Срок оценки: 90±14 days after enrollment]
  • Functional independence [Срок оценки: 90±14 days after enrollment]
  • Excellent outcome [Срок оценки: 90±14 days after enrollment]
  • National Institutes of Health Stroke Scale score [Срок оценки: 5-7 days after enrollment or discharge (whichever occurred first)]
  • Health-related quality of life [Срок оценки: 90±14 days after enrollment]
  • Incidence of symptomatic intracranial hemorrhage [Срок оценки: 48 hours after enrollment]
  • Incidence of any intracranial hemorrhage [Срок оценки: 48 hours after enrollment]
  • Incidence of decompressive hemicraniectomy [Срок оценки: 7 days after enrollment]
  • Mortality during hospitalization [Срок оценки: 7 days after enrollment]
  • Mortality [Срок оценки: 90±14 days after enrollment]
  • The occurrence of non-hemorrhagic serious adverse events [Срок оценки: through study completion, an average of 90 days]

Критерии участия

Критерии включения

Clinical inclusion criteria

  • Age ≥18 years;
  • Presenting with acute ischemic stroke within 24 hours of time from last known well;
  • The patient or patient's representative signs a written informed consent form before enrollment.

Neuroimaging inclusion criteria

  • Occlusion of internal carotid artery, or the middle cerebral artery M1 or M2 segments confirmed by computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography;
  • The baseline ASPECTS is 0 to 2 based on NCCT or diffusion weighted imaging, or cerebral extra-large ischemic core volume ≥85ml (defined as relative cerebral blood flow <30% on CT perfusion or an apparent diffusion coefficient <620×10\^-6 mm2/s on MRI).

Критерии исключения

  • CT or MRI evidence of acute intracranial hemorrhage;
  • Evidence of mass effect with ventricular effacement, midline shift or herniation on baseline imaging;
  • Females who are pregnant, or those of childbearing, potential with positive urine or serum beta Human Chorionic Gonadotropin test;
  • Previous bleeding disorders, severe heart, liver or kidney disease, or sepsis;
  • Any terminal illness with life expectancy less than 6 months;
  • Participation in other clinical treatment trials.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Xiangtan Central Hospital — Xiangtan

Идентификаторы

NCT: NCT06210633 · XL STROKE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗