NCT07115511招募中不适用
Combined Recanalization Therapy for Acute Large Vessel Occlusion Stroke
Tianjin Huanhu Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Proportion of subjects with mRs score of 0-1 at 90 days after surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
experiment group（surgical treatment）
Experimental
干预措施: Surgery (Procedure)
control group（conservative therapy）
No Intervention
结局指标
主要结局
Proportion of subjects with mRs score of 0-1 at 90 days after surgery
时间窗: 90 days after recombined recanalization surgery
次要结局
- 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;(90 days after recombined recanalization surgery)
- The mRs score changed from baseline at 90 days after surgery(90 days after recombined recanalization surgery)
- Change from baseline in MOCA score at 90 days after surgery(90 days after recombined recanalization surgery)
- Change from baseline in MMSE score at 90 days after surgery(90 days after recombined recanalization surgery)
研究者
Gao Kaiming
DOC.
Tianjin Huanhu Hospital
研究点 (1)
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