Comparison of Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting

NCT00640406 | Completed Phase 3 DMC

• 1 other identifier: C0701
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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).

Conditions

Renal Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Difference between treatments in change of estimated glomerular filtration rate (eGFR)

  12 months

Study Arms (2)

STN

EXPERIMENTAL

Device: Dynamic Renal Stent plus Best Medical Treatment

Device: Dynamic Renal Stent plus Best Medical Treatment

BMT

ACTIVE COMPARATOR

Drug: Best Medical Treatment

Drug: Best Medical Treatment

Interventions

Dynamic Renal Stent plus Best Medical Treatment DEVICE

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

STN

Best Medical Treatment DRUG

best medical treatment for hypertension secondary to renal artery stenosis according to local standards

BMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (1)

Herzzentrum Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

Location

Related Publications (2)

• 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.

  PMID: 28807045 DERIVED

• 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.

  PMID: 19635148 DERIVED

MeSH Terms

Conditions

Renal Artery Obstruction

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Thomas Zeller, PD Dr. med

  Dep. of Angiology, Herzzentrum Bad Krozingen, Südring 15, 79189 Bad Krozingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 21, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

DE (1)