A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)
研究概览
简要总结
Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries.
详细描述
Feasibility study to assess safety of treating patients with self expanding stent in intracranial arteries. Patients will be followed for 6 months with assessments related to technical feasibility and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Contact site for specific information
- •Inclusion Criteria:
- •Subject meet specific criteria for treatment
- •Subject must be willing to return to site for 30 day and 6 month follow up evaluations
排除标准
- •Stenting, angioplasty or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date
- •Previously implanted carotid stent associated with the symptomatic distribution within the past 12 weeks
结局指标
主要结局
Technical Feasibility- Successful Stent/Coil Placement (Post Procedure)
时间窗: post procedure
Successful placement of the product assessed immediately post procedure
Technical Feasibility- Percent Occlusion (Post Procedure)
时间窗: post procedure
Occlusion evaluated immediately post procedure
Technical Feasibility- Percent Occlusion (6 Mo Post Procedure)
时间窗: 6 mo
6 Months post
Technical Feasibility- Successful Stent/Coil Placement (6 Mo Post Procedure)
时间窗: 6 mo
Successful stent/coil placement assessed at 6 mo post
Technical Feasibility- Percent Stenosis (6 mo Post Procedure)
时间窗: 6 mo
Percent Stenosis assessed 6 mo Post Procedure from pre-procedure
Technical Feasibility- Percent Stenosis (Post Procedure)
时间窗: Post Procedure
Percent Stenosis assessed immediately post procedure from pre procedure
次要结局
- The Secondary Outcome Measure in Group 1, Atherosclerosis and in Group 2, Aneurysm, is the Evaluation of Adverse Events. The Groups Were Analyzed Separately.(6 months)