The ViVEXX Carotid Revascularization Trial (VIVA) for High Surgical Risk Patients With Extracranial Carotid Artery Stenosis Using the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 407
- 主要终点
- Percentage of Patients Experiencing Major Adverse Events (MAE)
研究概览
简要总结
To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid endarterectomy.
详细描述
Patients with clinically significant stenosis within the common and/or internal carotid artery who are at high risk for carotid endarterectomy and are amenable to percutaneous treatment including embolic protection, balloon angioplasty and the carotid stent placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a symptomatic or asymptomatic carotid artery stenosis that meets one of the following criteria:
- •Symptomatic: > than or = to 50% carotid stenosis by angiography and a history of non-disabling stroke, transient ischemic attack (TIA) in the hemisphere supplied by the target vessel within 180 days of the procedure.
- •Asymptomatic: > than or = to 80% carotid stenosis by angiography without neurological symptoms.
- •High risk for carotid endarterectomy: anatomical and co-morbid.
排除标准
- •History of symptoms of stroke or TIA within 24 hours of the procedure
- •Extensive or diffuse atherosclerotic disease
- •Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device
结局指标
主要结局
Percentage of Patients Experiencing Major Adverse Events (MAE)
时间窗: 365 days from implantation
A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure.
次要结局
- Number of Participants Experiencing Stroke Related Neurologic Deficit(30 days from implantation)
- Number of Participants Experiencing Device Success(at time of implantation)
- Number of Participants Experiencing Lesion Success(at time of implantation)
- Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)(12 months from implantation)
- Number of Patients Experiencing Access Site Complications(30 days following implantation)
- Number of Participants Experiencing Restenosis(12 months after implantation)