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

Medical University of Vienna

Status and phase: Unknown; Phase 4

Conditions: Renal Artery Stenosis

Treatments: Device: Herkulink renal artery Stent; Other: best medical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00711984

Version 1.0-2003

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

1

Active Comparator group

Description:

Renal artery stenting and Best medical treatment

Treatment:

Device: Herkulink renal artery Stent

Other: best medical therapy

2

Active Comparator group

Description:

Best medical treatment alone

Treatment:

Other: best medical therapy