Renal Artery Stenosis
Conditions
Keywords
renal artery stenosis, stent, comparison of treatments, progression, atherosclerosis, peripheral artery disease, major cardiovascular events
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.
Interventions
DEVICEHerkulink renal artery Stent
renal artery stent
OTHERbest medical therapy
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
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in mean blood pressure and renal function occurrence of major cardiovascular events | 3, 6, 9, 12 months, annually |
Secondary
| Measure | Time frame |
|---|---|
| progression of the degree of RAS in the conservative group and restenosis rate in the stent group | 6, 12 months, annually |
Countries
Austria
Contacts
Primary ContactErich Minar, Prof. Dr.
Backup ContactMartin Schillinger, Prof. Dr.
Outcome results
None listed