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

Phase 4

• Conditions: Renal Artery Stenosis
• Interventions: Device: Herkulink renal artery Stent; Other: best medical therapy

• Registration Number: NCT00711984
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-09
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-25
• Last Update Posted: 2011-07-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Herkulink renal artery Stent	Renal artery stenting and Best medical treatment
1	best medical therapy	Renal artery stenting and Best medical treatment
2	best medical therapy	Best medical treatment alone

Primary Outcome Measures

Name	Time	Method
change in mean blood pressure and renal function occurrence of major cardiovascular events	3, 6, 9, 12 months, annually

Secondary Outcome Measures

Name	Time	Method
progression of the degree of RAS in the conservative group and restenosis rate in the stent group	6, 12 months, annually

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria