跳至主要内容
临床试验/NCT00711984
NCT00711984Unknown4 期

Comparison of Stenting Versus Best Medical Therapy for Treatment of Ostial Renal Artery Stenosis: a Randomized Controlled Trial in Patients With Advanced Atherosclerosis.

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2004年2月最近更新:
适应症

试验速览

阶段
4 期
入组人数
120
试验地点
2
主要终点
change in mean blood pressure and renal function occurrence of major cardiovascular events

研究概览

简要总结

Renal artery stenosis (RAS) usually refers to a disease of the large extra-renal arterial vessels and most frequently is caused by atherosclerotic obstructions. The prevalence of atherosclerotic RAS increases with age, male gender, traditional cardiovascular risk factors (hypertension, diabetes, smoking, hyperlipidemia) and atherosclerotic comorbidities like coronary artery or peripheral artery disease (PAD). A prevalence up to 40% has been reported in patients with PAD. Undoubtedly, atherosclerotic RAS is a progressive disease, as more than half of the patients exhibit an increasing degree of stenosis within five years after diagnosis, and one out of five patients with a critical stenosis (>60%) suffers renal atrophy and renal failure during this period. RAS may be treated conservatively by so called best medical treatment, surgically, or by endovascular interventions using balloon angioplasty and stenting.

The purpose of the investigators study is to determine the incidence and the predictors of RAS in patients with PAD, and to compare the effect of renal artery stenting versus best medical treatment in patients with hypertension and ostial renal artery stenosis in a randomized controlled trial.

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

入选标准

  • PAD and unilateral ostial >60% RAS and hypertension

排除标准

  • Conditions which imply RAS stenting (bilateral significant renal disease, single functioning kidney, or patients whose conditions cannot be managed medically or by intervention)
  • Allergy to contrast agents or medication administered for best medical treatment (in particular ASA and statins)

结局指标

主要结局

change in mean blood pressure and renal function occurrence of major cardiovascular events

时间窗: 3, 6, 9, 12 months, annually

次要结局

  • progression of the degree of RAS in the conservative group and restenosis rate in the stent group(6, 12 months, annually)

研究者

申办方类型
Other

研究点 (2)

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