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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
  Purpose

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.


Condition Intervention Phase
Renal Artery Stenosis
Device: Herkulink renal artery Stent
Other: best medical therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: February 2004
Arms Assigned Interventions
Active Comparator: 1
Renal artery stenting and Best medical treatment
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: 2
Best medical treatment alone
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711984

Contacts
Contact: Erich Minar, Prof. Dr. erich.minar@meduniwien.ac.at
Contact: Martin Schillinger, Prof. Dr. martin.schillinger@meduniwien.ac.at

Locations
Austria
Medical University Vienna Recruiting
Vienna, Austria, 1090
Principal Investigator: Erich Minar, Prof.Dr.         
Principal Investigator: Martin Schillinger, Prof.Dr.         
Sub-Investigator: Jasmin Amighi, Dr.         
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Prof. Dr. Erich Minar, Medical University Vienna
ClinicalTrials.gov Identifier: NCT00711984     History of Changes
Other Study ID Numbers: Version 1.0-2003
Study First Received: July 3, 2008
Last Updated: July 25, 2011
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
renal artery stenosis
stent
comparison of treatments
progression
atherosclerosis
peripheral artery disease
major cardiovascular events

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Constriction, Pathologic
Renal Artery Obstruction
Arterial Occlusive Diseases
Cardiovascular Diseases
Kidney Diseases
Pathological Conditions, Anatomical
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014