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

NCT00711984 | Unknown Phase 4

• 1 other identifier: Version 1.0-2003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Artery Stenosis

Keywords

renal artery stenosis; stent; comparison of treatments; progression; atherosclerosis; peripheral artery disease; major cardiovascular events

Outcome Measures

Primary Outcomes (1)

• change in mean blood pressure and renal function occurrence of major cardiovascular events

  3, 6, 9, 12 months, annually

Secondary Outcomes (1)

• progression of the degree of RAS in the conservative group and restenosis rate in the stent group

  6, 12 months, annually

Study Arms (2)

1

ACTIVE COMPARATOR

Renal artery stenting and Best medical treatment

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

2

ACTIVE COMPARATOR

Best medical treatment alone

Other: best medical therapy

Interventions

Herkulink renal artery Stent DEVICE

renal artery stent

Also known as: Herkulink (renal stent) Guidant/Abbott Vascular

1

best medical therapy OTHER

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PAD and unilateral ostial \>60% RAS and hypertension

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Renal Artery Obstruction; Disease Progression; Atherosclerosis; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Peripheral Vascular Diseases

Central Study Contacts

Erich Minar, Prof. Dr.

CONTACT

erich.minar@meduniwien.ac.at

Martin Schillinger, Prof. Dr.

CONTACT

martin.schillinger@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 9, 2008
• Study Start: February 1, 2004
• Last Updated: July 26, 2011

Record last verified: 2011-07

Locations

AU (1)