NCT02594410已完成4 期
The Efficacy of Renal Artery Stent Combined With Standardized Medical Therapy in Patients With Atherosclerotic Renal Artery Stenosis
Lee's Pharmaceutical Limited1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Glomerular filtration rate
研究概览
简要总结
To evaluate the efficacy of renal artery stent combined with standardized medical therapy as treatment for renal artery stenosis.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 - 75
- •Diameter of stenosis of renal artery or main branch of renal artery ≥60％. If diameter of stenosis is 60% - 75%, pressure difference between proximal and distal end ≥20 mm Hg (1mmHg=0.133kPa) or Captopril renography positive;
- •Systolic blood pressure before taking antihypertensive ≥180mmHg and/or diastolic blood pressure ≥110 mmHg; taking three antihypertensive including one diuretics with systolic blood pressure ≥140mmHg and/or ≥90 mmHg;
- •length of ipsilateral kidney is greater than 7.0cm.
排除标准
- •Estimated glomerular filtration rate (eGFR) <30 ml/ (min﹒1.73 m 2) [eGFR (mL/min/1.73 m2) = 186.3 * serum creatinine (mg/dl) -1.154 * Age-0.203 * 0.742 (female)[11];
- •unstable condition and unable to tolerate interventional therapy;
- •anatomy of renal artery pathology not suitable for interventional therapy;
- •allergic to dihydropyridines;
- •III degree atrioventricular block
- •contrast allergy ;
- •any known malignant tumor;
- •non-compliant, history of alcoholism or drug abuse.
研究组 & 干预措施
Treatment
Experimental
patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis
干预措施: stent (Device)
Treatment
Experimental
patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis
干预措施: Aspirine (Drug)
Treatment
Experimental
patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis
干预措施: Clopidogrel (Drug)
Treatment
Experimental
patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis
干预措施: Lercanidipine (Drug)
结局指标
主要结局
Glomerular filtration rate
时间窗: 12 months
Blood pressure
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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