Standard Medical Treatment Plus Endovascular Treatment Versus Standard Medical Treatment Alone for Stroke Patient With Large Vessel Occlusion In The Posterior Circulation: A Multicenter, Randomized, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 386
- 试验地点
- 16
- 主要终点
- Modified Rankin scale score
研究概览
简要总结
The aim of this trial is to investigate whether endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.
详细描述
At least seven randomized controlled trials have consistently shown that endovascular treatment can improve the functional outcome of stroke patients with acute anterior large vessel occlusion. However, these trials did not include patients with large vessel occlusion in the posterior circulation.
The hypothesis of this trial: Compared with standard medical treatment alone, standard medical treatment combined with endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.
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
- Double (Care Provider, Outcomes Assessor)
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: i. 18 ~ 80 years old, pc-ASPECTS score ≥ 6; ii. > 80 years old, pc-ASPECTS score ≥ 8 and mRS = 0 before the onset
- •NIHSS score ≥ 10 before randomization;
- •VA-V4 or basilar artery occlusion proved by CTA/MRA/DSA;
- •Time from stroke onset to randomization within 23.5 hours;
- •Written informed consent is obtained from patients and/or their legal representatives.
排除标准
- •CT or MR evidence of intracranial hemorrhage;
- •Pre-morbidity with a modified Rankin scale score ≥ 3;
- •The patient is in deep coma;
- •Currently in pregnant or lactating or serum beta HCG test is positive on admission;
- •Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
- •Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;
- •Significant mass effect in the cerebellar hemisphere or hydrocephalus on imaging;
- •Imaging manifestations of diffuse bilateral brainstem ischemia;
- •Multivessel occlusive disease (combined with anterior and posterior circulation occlusion or subtotal occlusion);
- •Cerebral vasculitis, intracranial arteriovenous malformation, aneurysm, or brain tumor with mass effect;
- •Participating in other clinical trials;
- •Any terminal illness with life expectancy less than 6 months;
- •Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
- •Past neurological or psychiatric diseases that hinder the assessment of neurological function;
- •Unlikely to be available for 90-day follow-up.
研究组 & 干预措施
Intervention group
Standard medical treatment plus endovascular treatment
干预措施: Endovascular treatment (Procedure)
Intervention group
Standard medical treatment plus endovascular treatment
干预措施: Standard medical treatment (Other)
Control group
Standard medical treatment alone
干预措施: Standard medical treatment (Other)
结局指标
主要结局
Modified Rankin scale score
时间窗: 90 days
disability level
次要结局
- Improvement in GCS between baseline and 24 hours(at 5~7 days from randomization)
- Rate of a score of 0~2 on modified Rankin scale(90 days)
- Improvement in NIHSS between baseline and 24 hours(at 24 hours from randomization)
- Improvement in NIHSS between baseline and 5~7d(at 5~7 days from randomization)
- Asymptomatic intracranial hemorrhage within 48 hours(within 48 hours after endovascular treatment)
- Procedural-related complications and severe adverse events(within 90 days)
- Serious non-hemorrhagic adverse events(within 90 days)
- Score of 90-day EQ-5D scale(90 days)
- Mortality within 90 days(90 days)
- Symptomatic intracranial hemorrhage within 48 hours(within 48 hours after endovascular treatment)
- Improvement in GCS between baseline and 24 hours(at 24 hours from randomization)
研究者
Zhongming Qiu
Professor
Xinqiao Hospital of Chongqing