NCT00640406

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-12-01
• Completion: 2015-03-01
• First posted: 2008-03-21
• Last updated: 2015-07-21

Locations

1 site across 1 country: Germany