Simple Imaging Versus Standard Imaging Selection in Stroke Patients for Endovascular Treatment: the NO-SELECT Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,846
- 试验地点
- 8
- 主要终点
- favorable outcome at 90 days
研究概览
简要总结
Several studies suggest that advanced multi-modal imaging with CTP should be used to screen late time window stroke patients for thrombectomy. However, NCCT is more accessible when comparing with CTP. It is unclear whether the NCCT-based ASPECTS can be used as an imaging criterion to screen patients for thrombectomy.
The newly published MR CLEAN-LATE and TENSION trials used NCCT or CTA, but still relied on ASPECTS scores to evaluate and select patients for endovascular therapy. However, different trials have different time windows. The aim of this trial was to assess the clinical outcomes of stroke patients with anterior large vessel occlusion who selected by simple imaging (NCCT) comparing via standard imaging screening strategy (CTP/MRI). The hypothesis is that simple imaging is non-inferior to standard imaging selection strategy in terms of achieving favorable outcomes.
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
- Triple (Participant, 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
- •Aged 18 years or older;
- •The interval time from last known well to hospital arrival is within 24 hours;
- •Acute stroke confirmed by clinical symptoms or imaging examination;
- •Field Assessment Stroke Triage for Emergency Destination (FAST ED) ≥4;
- •Written informed consent is obtained from patients and/or their legal representatives.
排除标准
- •Allergy to radiographic contrast agents, or nitinol devices;
- •Currently pregnant or lactating (women patients);
- •Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
- •Preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
- •Multiple vessel occlusion (e.g., bilateral anterior circulation, or occlusion of both anterior and posterior circulation);
- •Brain tumors with mass effect (except meningiomas) that are radiographically pleasant;
- •Intracranial aneurysm, arteriovenous malformation;
- •Any terminal illness with life expectancy less than 6 months;
- •Unlikely to be available for 90-day follow-up.
结局指标
主要结局
favorable outcome at 90 days
时间窗: 90 days post-endovascular treatment
defined as modified Rankin scale score of 0 to 3. Modified Rankin scale score (mRS): scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
次要结局
- mortality at 90 days(90 days post-endovascular treatment)
- symptomatic intracranial hemorrhage within 48 hours(within 48 hours post-endovascular treatment)
研究者
Zhongming Qiu
Professor
Xinqiao Hospital of Chongqing