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

NCT00640406 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2015-07-21

No results posted yet for this study

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

Interventions

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

DRUG

Best Medical Treatment

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

Sponsors & Collaborators

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-12-31
Completion
2015-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00640406 on ClinicalTrials.gov