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

• Status: Unknown status
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Unità Sanitaria Locale di Piacenza
• Treatments: Antihypertensive Agents

Criteria

Inclusion Criteria:

• Age ≤ 80 years

• Presence of ostial renal artery stenosis ≥ 70% (determined by Duplex Doppler ultrasonography and confirmed by Magnetic Resonance valuated by at least two experienced operators)

• Serum creatinine ≤ 3 mg/dl and/or creatinine clearance (Modification of Diet in Renal Disease, MDRD formula)≥ 30 ml/min, defined as stage 3 or greater CKD based on National Kidney Foundation classification

• Longitudinal ultrasonographic diameter of the stenotic kidney ≥ 8 cm

• Blood pressure values ≤ 150/90 mmHg with the use of less than four hypotensives drugs

Exclusion Criteria:

• Age > 80 years

• Other well-known nephropathy cause of renal failure

• Duplex doppler ultrasonography Resistive Index values >0.8

• Total occlusion of renal artery lumen

• Occurrence of cerebral or cardiac vascular diseases in the 6 months before the enrolment in the study

• Malignancy with a life expectation less than one year

• Previous documented cholesterol thrombo embolization episodes (clinically, bioptically or instrumentally)

• Liver failure

• Cardiac failure (NYHA IV class) or instable angina

• Well-known intolerance or contraindications to the use of iodinated contrast media, to statins or to anti platelets drugs

• Previous renal angioplasty

• Pregnancy