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

Biotronik AG1 site in 1 country86 target enrollmentApril 2008

ConditionsRenal Artery Stenosis

InterventionsDynamic Renal Stent plus Best Medical Treatment Best Medical Treatment

DrugsBest Medical Treatment

Overview

Phase: Phase 3
Intervention: Dynamic Renal Stent plus Best Medical Treatment
Conditions: Renal Artery Stenosis
Sponsor: Biotronik AG
Enrollment: 86
Locations: 1
Primary Endpoint: Difference between treatments in change of estimated glomerular filtration rate (eGFR)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

March 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biotronik AG

Responsible Party

Sponsor

Eligibility 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,