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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Biotronik AG.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Biotronik AG
ClinicalTrials.gov Identifier:
NCT00640406
First received: March 17, 2008
Last updated: May 17, 2011
Last verified: May 2011
  Purpose

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).


Condition Intervention Phase
Renal Artery Stenosis
Device: Dynamic Renal Stent plus Best Medical Treatment
Drug: Best Medical Treatment
Phase 3

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

Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • Difference between treatments in change of estimated glomerular filtration rate (eGFR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640406

Locations
Germany
Herzzentrum Bad Krozingen
Bad Krozingen, Baden-Württemberg, Germany, 79189
Sponsors and Collaborators
Biotronik AG
Investigators
Principal Investigator: Thomas Zeller, PD Dr. med Dep. of Angiology, Herzzentrum Bad Krozingen, Südring 15, 79189 Bad Krozingen, Germany
  More Information

No publications provided by Biotronik AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Esther Gerteis, Director Clinical Affairs, BIOTRONIK AG
ClinicalTrials.gov Identifier: NCT00640406     History of Changes
Other Study ID Numbers: C0701
Study First Received: March 17, 2008
Last Updated: May 17, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 23, 2014