Endovascular Treatment for Posterior Circulation Ischemic Stroke Post 1 Day （24 Hours） A Randomized Controlled Clinical Trial On Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Proportion of patients with an mRS score of 0-3 at 90 days
研究概览
简要总结
To evaluate the efficacy and safety of endovascular therapy for posterior circulation ischemic stroke presenting more than 24 hours after symptom onset.
详细描述
This study is a multicenter, open-label, blinded-endpoint, randomized controlled trial designed to evaluate the efficacy and safety of endovascular treatment administered beyond 24 hours after the onset of posterior circulation ischemic stroke. A total of 244 patients (122 per group) will be enrolled, aged ≥18 years, with a baseline NIHSS score ≥4, onset of stroke or last known well time >24 hours and within 14 days, and confirmed occlusion of the basilar artery or the intracranial segment of bilateral vertebral arteries as the culprit vessel. Patients will be randomly assigned to the experimental group (endovascular treatment plus standard medical therapy) or the control group (standard medical therapy alone). The primary endpoint is the proportion of patients with a 90-day modified Rankin Scale (mRS) score of 0-3. Secondary endpoints include the distribution of 90-day mRS scores, the proportion of patients with a 90-day mRS score of 0-2, and the 90-day EQ-5D-5L scale score. The study is led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology as the coordinating center and will be conducted at multiple centers across China, with a planned duration of 36 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Baseline NIHSS score of 4 or higher, maintained prior to randomization
- •Stroke onset or more than 24 hours since the last known good state, but within 14 days
- •CTA/MRA/DSA confirmed occlusion of the responsible vessel in basilar artery or intracranial segments of both vertebral arteries (V4)
- •Modified Rankin Scale (mRS) score of 0 or 1 pre-stroke
- •The subject or their legally authorized representative has signed the informed consent form for the study
排除标准
- •Hemorrhage on CT or MRI
- •Based on the judgment of the treating physician, the patient is considered unlikely to benefit from the trial (e.g., advanced dementia, severe pre-stroke disability (mRS ≥ 2), or high risk of early mortality)
- •Major comorbidities that may interfere with outcome assessment and follow-up (e.g., severe heart failure, renal failure, etc.).
- •Evidence of vascular recanalization prior to randomization
- •Uncontrolled seizures at the time of stroke onset, if they interfere with obtaining an accurate baseline NIHSS
- •Posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) < 6 on non-contrast CT or CT angiography source images or MR with diffusion-weighted imaging
- •Complete cerebellar infarct with significant mass effect and compression of the fourth ventricle,or bilateral thalamic infarction on CT or MRI
- •Baseline platelet count <50,000/uL
- •Severe, persistent hypertension (systolic blood pressure > 220 mmHg or diastolic blood pressure > 120 mmHg)
- •Known hereditary or acquired bleeding disorders, coagulation factor deficiencies, or recent oral anticoagulant therapy with an International Normalized Ratio (INR) > 3
- •Suspected purulent embolism, with a suspicion of bacterial endocarditis
- •Known allergies to iodine, heparin, anesthetics, or other explicit contraindications to the endovascular treatment procedure
- •Other serious, progressive, or end-stage diseases (as determined by the investigator) or a life expectancy of less than 6 months
- •Attempted use of a neurothrombectomy device to remove the clot prior to randomization
- •Currently participating in a study involving other investigational drugs or devices
- •Evidence of intracranial tumor on CT or MRI (excluding meningioma)
- •CTA/MRA showing excessive tortuosity of the cervical vessels, which may interfere with endovascular treatment
- •Suspicion of aortic dissection based on medical history and CTA/MRA findings
- •Any other conditions that the investigator believes may interfere with the endovascular procedure or pose significant risk to the subject during the procedure
研究组 & 干预措施
Test group
Endovascular treatment combined with standard pharmacological treatment
干预措施: Endovascular treatment combined with standard pharmacological treatment (Procedure)
control group
Standard pharmacological treatment
干预措施: Standard pharmacological treatment (Drug)
结局指标
主要结局
Proportion of patients with an mRS score of 0-3 at 90 days
时间窗: 90days
次要结局
- Symptomatic intracranial hemorrhage (sICH) (defined as a worsening of NIHSS by 4 or more points within 24 hours after random treatment, associated with intracranial hemorrhage)(24hours)
- Surgical-related complications(Post procedure 24hours)
- Stroke-related mortality at 90 days(90days)
- EQ-5D-5L scale score at 90 days(90days)
- New onset of stroke within 90 days(90days)
- Hematoma of any type at 24 hours (-6/+24) after random treatment(24hours)
- The distribution of mRS scores at 90 days post-randomization(90days)
- All-cause mortality at 90 days(90days)
- Proportion of patients with an mRS score of 0-2 at 90 days(90days)
研究者
Hu Bo
Director, Head of Neurology, Principal Investigator, Clinical Professor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology