Comparison of Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting (RADAR)

July 20, 2015 updated by: Biotronik AG

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Bad Krozingen, Baden-Württemberg, Germany, 79189
        • Herzzentrum Bad Krozingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STN
Device: Dynamic Renal Stent plus Best Medical Treatment
Device: Dynamic Renal Stent plus Best Medical Treatment
percutaneous transluminal angioplasty of the kidney artery at index procedure followed by best medical treatment for hypertension secondary to renal artery stenosis according to local standards
Active Comparator: BMT
Drug: Best Medical Treatment
Drug: Best Medical Treatment
best medical treatment for hypertension secondary to renal artery stenosis according to local standards

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between treatments in change of estimated glomerular filtration rate (eGFR)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik AG

Investigators

  • Principal Investigator: Thomas Zeller, PD Dr. med, Dep. of Angiology, Herzzentrum Bad Krozingen, Südring 15, 79189 Bad Krozingen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 21, 2008

Study Record Updates

Last Update Posted (Estimate)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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