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

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Artery Stenosis

Intervention / Treatment
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* Device: Herkulink renal artery Stent
* Other: best medical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PAD and unilateral ostial >60% RAS and hypertension Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Renal artery stenting and Best medical treatment | Device: Herkulink renal artery Stent<br>* renal artery stent<br>* Other names: Herkulink (renal stent) Guidant/Abbott Vascular;Other: best medical therapy<br>* All patients will receive best medical therapy according to current guidelines consisting in antihypertensive, antiplatelet, antidiabetic and lipid-lowering medication and in recommendation of lifestyle modification<br>|
| Active Comparator: 2<br>Best medical treatment alone | Other: best medical therapy<br>* All patients will receive best medical therapy according to current guidelines consisting in antihypertensive, antiplatelet, antidiabetic and lipid-lowering medication and in recommendation of lifestyle modification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in mean blood pressure and renal function occurrence of major cardiovascular events |  | 3, 6, 9, 12 months, annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression of the degree of RAS in the conservative group and restenosis rate in the stent group |  | 6, 12 months, annually | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal artery stenosis, stent, comparison of treatments, progression, atherosclerosis, peripheral artery disease, major cardiovascular events