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
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
- Atherosclerosis
- Chronic Kidney Disease
- Hypertension, Renovascular
- Ischemic Nephropathy
- Renal Artery Stenosis
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
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