Clinical trial NCT00640406: Comparison of Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting
Official title: A Randomized, Multi-centre, Prospective Study Comparing Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting in Patients With Hemodynamically Relevant Atherosclerotic Renal Artery Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Artery Stenosis
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow ups at 2, 6, 12 months and 3 years.

The purpose of the study is to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS) on the impaired renal function measured by the estimated Glomerular Filtration Rate (eGFR) in patients with hemodynamically significant atherosclerotic renal artery stenosis (ARAS).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Informed consent signed by patient (and/or legal guardian),
* Hemodynamically relevant de novo unilateral or bilateral atherosclerotic renal artery diameter stenosis RAS (≥ 70%)
* Estimated GFR \> 10 ml/min calculated using the abbreviated Modification of Diet in Renal Disease (MDRD) Study equation,
* Patients presenting mild, moderate or severe hypertension (defined according to the WHO guidelines) and/or renal dysfunction,
* Target lesion must be completely coverable by one study stent,
* Total target lesion length estimated to be less than 19 mm,
* Target lesion accessible to direct stenting or, after pre-dilation, is likely to sufficiently benefit from stenting (at the discretion of the investigator),
* Renal reference vessel diameter (RVD) of ≥ 4.0 mm and \< 7.0 mm based on visual estimation,
* Willingness to comply with all the specified follow-up evaluations.

Exclusion Criteria:

* Estimated GFR ≤ 10 ml/min,
* Renal atrophy or kidney length \< 7cm (referring to kidney with target lesion),
* Patient not eligible for PTRAS,
* Patient not eligible for stenting,
* Target lesion occlusion,
* Target lesion and/or target vessel proximal to the target lesion is severely calcified,
* Treatment of branch lesion required,
* Fresh thrombus or embolic lesion
* Need for embolic protection in previous or planned PTRAS,
* Clotting disorders,
* INR \> 2.5 before the intervention,
* Patient presents fibromuscular dysplasia,
* Prior revascularization of target lesion,
* History of target vessel revascularization within the last six months,
* Angiographic restenosis of any segment of the target vessel that has undergone prior percutaneous intervention,
* Any thrombolytic therapy procedure within 72 hours prior to planned study procedure
* Active peptic ulcer or gastro intestinal bleeding,
* Active inflammation of the kidney interfering with diagnosis and treatment of RAS (e.g. glomerulonephritis, aortitis, vasculitis),
* Radiation damage of the kidney,
* Renal disease associated with aortic aneurysm i.e. diameter of the aorta \> 40 mm,
* Chronic renal replacement therapy,
* Life expectancy \< 1 year,
* Co-morbid conditions limiting participation and follow-up
* Patient currently participating in another trial possibly influencing the safety of the patient and/or the outcomes of the study,
* Pregnancy/Planned pregnancy/Childbearing potential without sufficient measures to prevent pregnancy as judged by the investigator,
* Known allergy to contrast medium that cannot be adequately controlled with pre-medication,
* Known intolerance against acetylic-salicylic acid (ASA), heparin, clopidogrel and ticlopidin, cobalt-chromium,
* Metformin intake not stopped at least 48 hours before the intervention

Primary outcomes:
measure: Difference between treatments in change of estimated glomerular filtration rate (eGFR)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
state: Baden-Württemberg
Study officials:
affiliation: Dep. of Angiology, Herzzentrum Bad Krozingen, Südring 15, 79189 Bad Krozingen, Germany
name: Thomas Zeller, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeller T, Krankenberg H, Erglis A, Blessing E, Fuss T, Scheinert D, Weser R, Doerr BB, Yollo WD, Radermacher J; RADAR Investigators. A randomized, multi-center, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with hemodynamically relevant atherosclerotic renal artery stenosis (RADAR) - one-year results of a pre-maturely terminated study. Trials. 2017 Aug 14;18(1):380. doi: 10.1186/s13063-017-2126-x.
citation: Schwarzwalder U, Hauk M, Zeller T. RADAR - A randomised, multi-centre, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with haemodynamically relevant atherosclerotic renal artery stenosis. Trials. 2009 Jul 27;10:60. doi: 10.1186/1745-6215-10-60.