Combined Recanalization Therapy for Acute Large Vessel Occlusion Stroke

Обзор

The purpose of this clinical trial is to evaluate the efficacy and safety of combined recanalization therapy in patients who cannot be recanalized by acute large vessel occlusive stroke. The main questions it aims to answer are: 1、Proportion of subjects with mRs score of 0-1 at 90 days after surgery Participants will: 1、In acute large vessel occlusive stroke, if traditional means cannot be recanalized, combined recanalization surgery (including arteriotomy and thrombectomy, cerebrovascular bypass surgery) is performed.

Вмешательства

• Процедура Surgery
  Recombined recanalization surgery

Первичные конечные точки

• Proportion of subjects with mRs score of 0-1 at 90 days after surgery [Срок оценки: 90 days after recombined recanalization surgery]

Вторичные конечные точки (4)

• Changes in NIHSS score at 24 hours after surgery, 7 days after surgery, 30 days after surgery and 90 days after surgery compared with baseline; [Срок оценки: 90 days after recombined recanalization surgery]
• The mRs score changed from baseline at 90 days after surgery [Срок оценки: 90 days after recombined recanalization surgery]
• Change from baseline in MOCA score at 90 days after surgery [Срок оценки: 90 days after recombined recanalization surgery]
• Change from baseline in MMSE score at 90 days after surgery [Срок оценки: 90 days after recombined recanalization surgery]

Критерии участия

Критерии включения

• Age: 18-75.
• According to the current guidelines, there is a MT indication.
• Before stroke, mRS ≤2;
• ASPECTS ≥6;
• MCA occlusion, with or without ICA occlusion;
• MT unsuccessful, TICI score 0-1;
• Time from onset to craniotomy expected to be 24 hours or less;
• Post-awakening stroke with mismatch between the infarct zone and the penumbra zone;

Критерии исключения

• Comorbid hemorrhagic vascular disease such as intracranial aneurysm or vascular malformation or other planned cerebrovascular surgery that may alter cerebral hemodynamics or lead to stroke;
• unstable angina or myocardial infarction, congestive heart failure within the previous 6 months;
• Pregnancy or perinatal period;
• Hematologic disorders resulting in coagulation disorders;
• Combination of other diseases with a life expectancy of less than 2 years; and
• previous treatment with intracranial or extracranial vascular bypass surgery;
• allergy to iodine or X-ray contrast media, creatinine >3.0 mg/dl or other contraindications to arteriography;
• Uncontrolled diabetes mellitus, fasting blood sugar (FBS) >16.7 mmol/L;
• Uncontrolled hypertension with sitting systolic blood pressure >180 mmHg or sitting diastolic blood pressure >110 mmHg;
• Severe hepatic dysfunction, defined as serum alanine aminotransferase (ALT) and/or alanine aminotransferase (AST) >3 times the upper limit of normal;
• Platelets <100×109 /L.
• Received a clinical trial drug or device within 30 days prior to screening, or is participating in another clinical trial;
• contraindication to general anesthesia or craniotomy;
• other diseases or medical history that, in the investigator's judgment, may affect the efficacy or safety evaluation of this study.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Huahu Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07115511 · CRTALVOS2025 · tianjin Huanhu hospital

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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