Revascularization of Renal Artery Stenosis Versus Medical Therapy for the Treatment of Ischemic Nephropathy

NCT01023373 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2009-12-02

No results posted yet for this study

Summary

The aim of the study is to value, in patients with chronic kidney disease and hypertension, whether medical therapy plus interventional renal artery revascularization is superior to medical therapy alone for the treatment of hemodynamically significant (\>70%) atherosclerotic renal artery stenosis, diagnosed by duplex doppler ultrasonography and confirmed by magnetic resonance angiography, in terms of avoidance of the progression of renal damage, control of hypertension and in reducing the cerebro and cardiovascular complications.

Conditions

Interventions

DRUG

Medical treatment

hypotensive drugs, statins and anti-platelets

PROCEDURE

PTRS

Percutaneous transluminal renal artery stenting. The same medical therapy, as in group A, plus PTRS

DEVICE

renal artery stent

Non-drug intervention, percutaneous transluminal renal artery stent angioplasty

DEVICE

renal artery stent

Adding the renal artery stenting (in group B) to the optimal medical therapy (as in group A) that includes hypotensive drugs, statins and antiplatelet therapy

Sponsors & Collaborators

  • Azienda Unita Sanitaria Locale di Piacenza

    lead OTHER

Principal Investigators

  • Roberto Scarpioni · Divisione Nefrologia e Dialisi, "Guglielmo da Saliceto" Hospital, Azienda USL Piacenza, Italy

  • Emanuele Michieletti · U.O. Radiologia II "Guglielmo da Saliceto" Hospital, Piacenza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2008-09-30
Completion
2009-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

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 NCT01023373 on ClinicalTrials.gov