Carotid Artery Stenting Without Embolic Protection: A Randomized Multicenter Trial (the CASWEP Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 279
- 试验地点
- 6
- 主要终点
- The number of patients experiencing new ischemic brain lesions on diffusion-weighted magnetic resonance imaging (DWMRI), transient ischemic attack (TIA), Stroke and death events.
研究概览
简要总结
A recent randomized Carotid artery stenting (CAS) trial in which carotid protection device (CPD)s were used to demonstrate equivalence with carotid endarterectomy (CEA) by achieving noninferiority regarding periprocedural risk. However, the clinical efficacy and safety of CPDs are still a matter of controversy. It has been argued that the limited reduction provided by CPDs may be due to the devices themselves. Probably, they serve as sources for emboli during the procedure or removal technique. In general, 30- day adverse outcome for CAS with the use of CPDs seems not to be different from the outcome without CPDs.
Thus, the main goal in this study is to test the hypothesis that CAS without CPD usage is as safe as in those patients who undergo CAS with CPD neuroprotection.
详细描述
The Carotid Artery Stenting without Embolic Protection (CASWEP) trial is designed in a prospective, randomized, multi-center fashion to determine if CAS without CPD is feasible and safe in patients with symptomatic or asymptomatic severe carotid stenosis.
Study participants After the exclusion criterias were applied 279 patients were divided as 139 patients in the CAS with CPD arm and 140 patients in the CAS without CPD arm. Our study population includes patients with severe carotid artery stenosis referred to the 3 study center hospitals.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic patients with ≥ 50% ipsilateral carotid stenosis by angiography, ≥70% by duplex ultrasound, or ≥70% by Computerized tomography (CT) angiography or Magnetic Resonance (MR) angiography if the stenosis on ultrasonography was 50% to 69%.
- •Asymptomatic patients with ≥60% stenosis by angiography, ≥70% by ultrasound, or ≥80% by CT angiography or MR angiography if the stenosis on ultrasonography was 50% to 69%.
排除标准
- •Total occlusion,
- •Visible thrombus at the lesion site
- •Bleeding diathesis
- •Cerebral vascular malformation,
- •Degenerative cerebral diseases
- •Cerebral tumors
- •Illness impeding informed consent
- •Life expectancy<2 years
- •Previous CEA.
结局指标
主要结局
The number of patients experiencing new ischemic brain lesions on diffusion-weighted magnetic resonance imaging (DWMRI), transient ischemic attack (TIA), Stroke and death events.
时间窗: through hospital admission, an average of 2 days
peri-procedural in hospital outcome
次要结局
未报告次要终点