NCT01438229已完成不适用
Ablation-induced Renal Sympathetic Denervation Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 7
- 主要终点
- Adverse Events
研究概览
简要总结
This is a prospective, multicenter, feasibility study on the safety and efficacy of renal denervation in patients with resistant hypertension.
详细描述
Demonstrate the safety and efficacy of the St. Jude Medical Radiofrequency (RF) Renal Denervation System in the treatment of patients with resistant hypertension.
Safety Marker
- All adverse events
Efficacy Marker
- Office blood pressure
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic, for a minimum of 14 days prior to enrollment
- •Age ≥18 and ≤80 years old
- •Able and willing to provide written informed consent to participate in the study
- •Able and willing to comply with the required follow-up schedule
排除标准
- •Prior renal artery intervention (balloon angioplasty or stenting)
- •Evidence of renal artery atherosclerosis (defined as a stenotic severity of >30%) in either renal artery
- •Multiple main renal arteries in either kidney
- •Main renal arteries <4 mm in diameter or <20 mm in length
- •eGFR of <45 mL/min per 1.73 m2 using the MDRD formula
- •Type 1 diabetes
- •Renovascular hypertension or hypertension secondary to other renal disorders (glomerulonephritis, polycystic kidney disease, end-stage renal failure)
结局指标
主要结局
Adverse Events
时间窗: 24 months
All device or procedure related adverse events
Office Systolic Blood Pressure Change
时间窗: Baseline to 6 months
次要结局
未报告次要终点
研究者
研究点 (7)
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