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

Renal Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00711984
• Other study ID #: Version 1.0-2003
• Status: Recruiting
• Phase: Phase 4
• First received: July 3, 2008
• Last updated: July 25, 2011
• Start date: February 2004

Study information

• Verified date: July 2011
• Source: Medical University of Vienna
• Contact: Erich Minar, Prof. Dr.
• Email: erich.minar[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Constriction, Pathologic
• Renal Artery Obstruction
• Renal Artery Stenosis

Intervention

Device:
• Herkulink renal artery Stent
renal artery stent

Other:
• best 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

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in mean blood pressure and renal function occurrence of major cardiovascular events		3, 6, 9, 12 months, annually	Yes
Secondary	progression of the degree of RAS in the conservative group and restenosis rate in the stent group		6, 12 months, annually	Yes