Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS

Обзор

Patients presenting with mild symptoms of acute ischemic stroke are common and account for approximately half of all acute ischemic stroke. About 30% of patients with minor stroke have a 90-day functional disability. Radiologically proven a large vessel occlusion (LVO) in patients with minor stroke is a well-established predictor of poor outcomes, while the poor outcomes following best medical management in patients with minor stroke with the underlying presence of a LVO are mainly driven by the occurrence of early neurological deterioration (END). Considering the well-known strong association between lack of arterial recanalization and END, endovascular therapy (EVT) appears as an attractive option to improve functional outcomes for LVO-related patients with stroke with mild symptoms. Whether EVT is safe and effective in patients with mild stroke with an LVO is currently debated, since these patients were typically excluded from the pivotal EVT trials. The current study aimed to further test the hypothesis that endovascular therapy would be superior to medical management with respect to functional recovery among low NIHSS patients caused by acute large-vessel occlusion in the anterior circulation.

Вмешательства

• Процедура Endovascular therapy
  Drug: Best medical management All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate. Procedure: Endovascular therapy In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used accordin
• Препарат Best medical management
  All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.

Первичные конечные точки

• 90-day excellent clinical outcome [Срок оценки: 90±7 days after randomization]

Вторичные конечные точки (2)

• Good clinical outcome [Срок оценки: 90±7 days after randomization]
• early recovery [Срок оценки: 72 hours after randomization]

Критерии участия

• Aged 18 years or older;
• The time from onset of acute ischemic stroke to arterial puncture is within 24 hours. Onset time is defined as the patient's Last Known Well (LKW);
• Low NIHSS score (2-5 points), with at least one of the following items:

• Altered mental status (lethargy or worse);
• Facial palsy (facial weakness score ≥ 1 point);
• Motor dysfunction (limb weakness score ≥ 1 point);
• Aphasia (language disturbance score ≥ 1 point);
• Hemispatial neglect (neglect score ≥ 1 point);
• Intracranial internal carotid artery, proximal M1 or M2 segment of middle cerebral artery occlusion (excluding tandem lesions) confirmed by cerebral CTA/MRA/DSA before randomization, which is identified as the culprit vessel for stroke;
• All patients receive CTP/MR perfusion imaging, with a volume of perfusion delay (Tmax>6 s) ≥ 50 mL;
• Written informed consent is obtained from the patient or legal surrogate, with agreement for long-term follow-up.

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

• The First Affiliated Hospital, Yijishan Hospital of Wannan Medical College — Wuhu

Идентификаторы

NCT: NCT06143488 · 2023090

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗