NCT00640406已完成3 期
A Randomized, Multi-centre, Prospective Study Comparing Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting in Patients With Hemodynamically Relevant Atherosclerotic Renal Artery Stenosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Difference between treatments in change of estimated glomerular filtration rate (eGFR)
研究概览
简要总结
The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow ups at 2, 6, 12 months and 3 years.
The purpose of the study is to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS) on the impaired renal function measured by the estimated Glomerular Filtration Rate (eGFR) in patients with hemodynamically significant atherosclerotic renal artery stenosis (ARAS).
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
- 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
- •Age ≥ 18 years
- •Informed consent signed by patient (and/or legal guardian),
- •Hemodynamically relevant de novo unilateral or bilateral atherosclerotic renal artery diameter stenosis RAS (≥ 70%)
- •Estimated GFR > 10 ml/min calculated using the abbreviated Modification of Diet in Renal Disease (MDRD) Study equation,
- •Patients presenting mild, moderate or severe hypertension (defined according to the WHO guidelines) and/or renal dysfunction,
- •Target lesion must be completely coverable by one study stent,
- •Total target lesion length estimated to be less than 19 mm,
- •Target lesion accessible to direct stenting or, after pre-dilation, is likely to sufficiently benefit from stenting (at the discretion of the investigator),
- •Renal reference vessel diameter (RVD) of ≥ 4.0 mm and < 7.0 mm based on visual estimation,
- •Willingness to comply with all the specified follow-up evaluations.
排除标准
- •Estimated GFR ≤ 10 ml/min,
- •Renal atrophy or kidney length < 7cm (referring to kidney with target lesion),
- •Patient not eligible for PTRAS,
- •Patient not eligible for stenting,
- •Target lesion occlusion,
- •Target lesion and/or target vessel proximal to the target lesion is severely calcified,
- •Treatment of branch lesion required,
- •Fresh thrombus or embolic lesion
- •Need for embolic protection in previous or planned PTRAS,
- •Clotting disorders,
- •INR > 2.5 before the intervention,
- •Patient presents fibromuscular dysplasia,
- •Prior revascularization of target lesion,
- •History of target vessel revascularization within the last six months,
- •Angiographic restenosis of any segment of the target vessel that has undergone prior percutaneous intervention,
- •Any thrombolytic therapy procedure within 72 hours prior to planned study procedure
- •Active peptic ulcer or gastro intestinal bleeding,
- •Active inflammation of the kidney interfering with diagnosis and treatment of RAS (e.g. glomerulonephritis, aortitis, vasculitis),
- •Radiation damage of the kidney,
- •Renal disease associated with aortic aneurysm i.e. diameter of the aorta > 40 mm,
- •Chronic renal replacement therapy,
- •Life expectancy < 1 year,
- •Co-morbid conditions limiting participation and follow-up
- •Patient currently participating in another trial possibly influencing the safety of the patient and/or the outcomes of the study,
- •Pregnancy/Planned pregnancy/Childbearing potential without sufficient measures to prevent pregnancy as judged by the investigator,
- •Known allergy to contrast medium that cannot be adequately controlled with pre-medication,
- •Known intolerance against acetylic-salicylic acid (ASA), heparin, clopidogrel and ticlopidin, cobalt-chromium,
- •Metformin intake not stopped at least 48 hours before the intervention
研究组 & 干预措施
STN
Experimental
Device: Dynamic Renal Stent plus Best Medical Treatment
干预措施: Dynamic Renal Stent plus Best Medical Treatment (Device)
BMT
Active Comparator
Drug: Best Medical Treatment
干预措施: Best Medical Treatment (Drug)
结局指标
主要结局
Difference between treatments in change of estimated glomerular filtration rate (eGFR)
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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