NCT02895386终止不适用
A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 25
- 主要终点
- Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure
研究概览
简要总结
To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.
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.
研究组 & 干预措施
Control Group B
Sham Comparator
Sham procedure and continuing current antihypertensive medications.
干预措施: Sham procedure (Other)
Treatment Group A
Active Comparator
ROX Coupler implantation and continuing antihypertensive medications.
干预措施: ROX Coupler (Device)
结局指标
主要结局
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure
时间窗: Baseline, 6 months
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline
次要结局
- Change in mean office systolic blood pressure(Baseline, 6 months)
研究者
研究点 (25)
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