Comparison of Stenting Versus Best Medical Therapy for Treatment of Ostial Renal Artery Stenosis: a Trial in Patients With Advanced Atherosclerosis
Primary Purpose
Renal Artery Stenosis
Status
Unknown status
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Herkulink renal artery Stent
best medical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Renal Artery Stenosis focused on measuring renal artery stenosis, stent, comparison of treatments, progression, atherosclerosis, peripheral artery disease, major cardiovascular events
Eligibility 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)
Sites / Locations
- Medical University ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Renal artery stenting and Best medical treatment
Best medical treatment alone
Outcomes
Primary Outcome Measures
change in mean blood pressure and renal function occurrence of major cardiovascular events
Secondary Outcome Measures
progression of the degree of RAS in the conservative group and restenosis rate in the stent group
Full Information
NCT ID
NCT00711984
First Posted
July 3, 2008
Last Updated
July 25, 2011
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00711984
Brief Title
Comparison of Stenting Versus Best Medical Therapy for Treatment of Ostial Renal Artery Stenosis: a Trial in Patients With Advanced Atherosclerosis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Stenosis
Keywords
renal artery stenosis, stent, comparison of treatments, progression, atherosclerosis, peripheral artery disease, major cardiovascular events
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Renal artery stenting and Best medical treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
Best medical treatment alone
Intervention Type
Device
Intervention Name(s)
Herkulink renal artery Stent
Other Intervention Name(s)
Herkulink (renal stent) Guidant/Abbott Vascular
Intervention Description
renal artery stent
Intervention Type
Other
Intervention Name(s)
best medical therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
change in mean blood pressure and renal function occurrence of major cardiovascular events
Time Frame
3, 6, 9, 12 months, annually
Secondary Outcome Measure Information:
Title
progression of the degree of RAS in the conservative group and restenosis rate in the stent group
Time Frame
6, 12 months, annually
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erich Minar, Prof. Dr.
Email
erich.minar@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Schillinger, Prof. Dr.
Email
martin.schillinger@meduniwien.ac.at
Facility Information:
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erich Minar, Prof.Dr.
First Name & Middle Initial & Last Name & Degree
Martin Schillinger, Prof.Dr.
First Name & Middle Initial & Last Name & Degree
Jasmin Amighi, Dr.
12. IPD Sharing Statement
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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
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