NCT00483808已完成1 期
Renal Denervation in Patients With Refractory Hypertension
Medtronic Vascular5 个研究点 分布在 2 个国家目标入组 73 人开始时间: 2007年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 5
- 主要终点
- To provide confirmation that renal denervation is safe and feasible.
研究概览
简要总结
To investigate the clinical utility of renal denervation in the treatment of refractory hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 years of age.
- •a systolic blood pressure of 160 mmHg or greater.
- •receiving and adhering to full doses of an appropriate antihypertensive drug regimen for a minimum of two weeks prior to screening.
- •agrees to have the study procedure(s) performed and additional procedures and evaluations, including repeat phlebotomy, imaging, urine analyses, and clinical examination.
- •competent and willing to provide written, informed consent to participate in this clinical study.
排除标准
- •renal arterial abnormalities
- •end stage renal disease requiring dialysis or renal transplant
- •serum Cr > 3, or calculated GFR < 45 ml/min
- •has experienced MI, unstable angina pectoris, or CVA with 6 months
结局指标
主要结局
To provide confirmation that renal denervation is safe and feasible.
时间窗: 3 years
次要结局
- Evidence of renal denervation; indication of physiologic response; assessment of device performance.(3 years)
研究者
研究点 (5)
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