NCT01682057已完成2 期
A Prospective, Non-Randomized, Open Label, Multi-Center Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients With Severe Hypertension
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in mean office SBP
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.
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
- •Diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination
排除标准
- •Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.
结局指标
主要结局
Change in mean office SBP
时间窗: Baseline, 6 months
Change in mean office SBP at six months as compared to Baseline
次要结局
- Change in mean office DBP(Change in mean office DBP six months as compared to Baseline)
研究者
研究点 (2)
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