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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00711984
First received: July 3, 2008
Last updated: July 25, 2011
Last verified: July 2011

July 3, 2008
July 25, 2011
February 2004
Not Provided
change in mean blood pressure and renal function occurrence of major cardiovascular events [ Time Frame: 3, 6, 9, 12 months, annually ] [ Designated as safety issue: Yes ]
course of mean blood pressure and renal function occurrence of major cardiovascular events [ Time Frame: 3, 6, 9, 12 months, annually ]
Complete list of historical versions of study NCT00711984 on ClinicalTrials.gov Archive Site
progression of the degree of RAS in the conservative group and restenosis rate in the stent group [ Time Frame: 6, 12 months, annually ] [ Designated as safety issue: Yes ]
progression of the degree of RAS in the conservative group and restenosis rate in the stent group [ Time Frame: 6, 12 months, annually ]
Not Provided
Not Provided
 
Comparison of Stenting Versus Best Medical Therapy for Treatment of Ostial Renal Artery Stenosis: a Trial in Patients With Advanced Atherosclerosis
Comparison of Stenting Versus Best Medical Therapy for Treatment of Ostial Renal Artery Stenosis: a Randomized Controlled Trial in Patients With Advanced Atherosclerosis.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Artery Stenosis
  • Device: Herkulink renal artery Stent
    renal artery stent
    Other Name: Herkulink (renal stent) Guidant/Abbott Vascular
  • 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
  • Active Comparator: 1
    Renal artery stenting and Best medical treatment
    Interventions:
    • Device: Herkulink renal artery Stent
    • Other: best medical therapy
  • Active Comparator: 2
    Best medical treatment alone
    Intervention: Other: best medical therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
Not Provided

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)
Both
18 Years and older
No
Contact: Erich Minar, Prof. Dr. erich.minar@meduniwien.ac.at
Contact: Martin Schillinger, Prof. Dr. martin.schillinger@meduniwien.ac.at
Austria
 
NCT00711984
Version 1.0-2003
No
Prof. Dr. Erich Minar, Medical University Vienna
Medical University of Vienna
Not Provided
Not Provided
Medical University of Vienna
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP