NCT02672462Unknown不适用
The Safety and Efficacy of a Renal Denervation System in Treating Patients With Hypertension: A Pilot Study
Shanghai Golden Leaf MedTec Co. Ltd1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- blood pressure
研究概览
简要总结
A single center, self-controlled pilot study on safety and efficacy of renal denervation in treatment of 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages of 18 to 75, male or female;
- •Main renal artery, with or without accessary renal arteries, with length
- •Patients who have not taken any anti-hypertensive drugs or have been off drugs for at least 2 weeks, with mean SBP ≥150mmHg and
- •180mmHg based on at least 3 office blood pressure measurements, or ASBP≥135mmHg and ≤170mmHg based on 24 hr blood pressure monitoring;
- •Agrees to take part in the trial and signs the written, informed consent.
排除标准
- •Renal artery abnormalities that are inappropriate for the procedure;
- •Pregnant or plan to become pregnant;
- •History of orthostatic hypotension;
- •Type I diabetes;
- •Estimated GFR<40mL/min/1.73m2;
- •Only one kidney or prior kidney transplantation;
- •Bleeding tendency or other coagulation related diseases;
- •Acute or severe systemic infection;
- •Prior renal artery interventional procedures or prior RDN treatment;
- •History of stroke or TIA;
- •Malignant tumor or end-stage illnesses;
- •Secondary hypertension;
- •Acute coronary events within 2 weeks;
- •Other conditions that deem unsuitable for the procedure, in the opinions of investigators.
结局指标
主要结局
blood pressure
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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