Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis

Официальное название

Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis (MAGIC): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial

Обзор

A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial that aims to evaluate the effect of immediate angioplasty (with or without stenting) for acute ischemic stroke (AIS) with severe intracranial atherosclerotic stenosis (ICAS) in improving the 90-day functional outcome.

Подробное описание

This study is a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the effect of immediate angioplasty (with or without stenting) for AIS with severe ICAS. The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-2.

Study intervention: (1) Participants in the intervention group will undergo immediate angioplasty (with or without stenting), and will receive the best medical treatment (BMT) after the procedure. (2) Participants in the control group will receive BMT alone.

This study is anticipated to enroll 412 participants.

Вмешательства

• Процедура Immediate angioplasty
  See arm/group descriptions.

Первичные конечные точки

• The modified Rankin Scale (mRS) 0-2 [Срок оценки: 90(±7) days]

Вторичные конечные точки (7)

• The mRS 0-1 [Срок оценки: 90(±7) days]
• The mRS 0-3 [Срок оценки: 90(±7) days]
• The shift analysis of the mRS distribution [Срок оценки: 90(±7) days]
• The change of National Institute of Health Stroke Scale (NIHSS) [Срок оценки: 7(±1) days or discharge, whichever came first]
• Any new stroke (ischemic/hemorrhagic) or all-cause mortality [Срок оценки: within 30 days]
• Any recurrent stroke in the territory of the target artery [Срок оценки: within 90 days]
• The quality of life [Срок оценки: 90(±7) days]

Критерии участия

Критерии включения

• Aged 18 years or older.
• Diagnosed with AIS and baseline NIHSS ≥6.
• Pre-stroke mRS ≤2.
• Time from symptom onset to randomization ≤ 24 hours; the onset time refers to "Last Known Well" (LKW).
• Non-contrast CT ASPECTS score ≥6.
• CTA confirmed severe ICAS (70-99%) of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery, and is presumed to be responsible for the stroke.
• Informed consent signed by the patient or authorized representative.

Критерии исключения

• Normal diameter of the culprit vessel <2.0 mm.
• Isolated perforator artery infarction (except for combined cortical hypoperfusion).
• Hemorrhagic stroke within the past 90 days.
• Cerebrovascular conditions such as vasculitis, moya-moya disease, arterial inflammatory stenosis, vasospasm, traumatic dissection, etc..
• Severe calcification at the stenosis site, where expected residual stenosis ≤50% cannot be achieved with procedure.
• Known cardiac thrombus source (e.g., atrial fibrillation, patent foramen ovale, infective endocarditis).
• INR >1.7 when using warfarin; coagulation dysfunction or uncorrectable bleeding factors.
• Platelet count <50×10\^9/L.
• Intracranial hemorrhage confirmed by CT or MRI.
• Women who are pregnant or breastfeeding.
• Participation in other intervention clinical trials.
• Known severe renal insufficiency with glomerular filtration rate <30 ml/min or blood creatinine >220 μmol/L (2.5 mg/dl).
• Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
• Aortic dissection.
• Concomitant intracranial tumor (except for meningioma <10mm) or arteriovenous malformation.
• Severe vascular tortuosity, difficult access for intervention, or inability to complete endovascular treatment.
• Any active bleeding or recent bleeding in the last 1 month.
• SBP>185 mmHg or DBP>110 mmHg refractory to treatment.
• Anticipated life expectancy <3 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
• Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).

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

• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Гуанчжоу
• Shenzhen Hospital of Southern Medical University — Шэньчжэнь

Идентификаторы

NCT: NCT06437600 · SYSKY-2024-337-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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