Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions

INCLUSION CRITERIA

• Either
• Documented history of hypertension on two or more anti-hypertensive medications OR
• Renal dysfunction, defined as Stage 3 or greater chronic kidney disease (CKD) based on the new National Kidney Foundation (NKF) classifications (estimated glomerular filtration rate [GFR] less than 60 mL per minute per 1.73 m^2, calculated by the modified Modification of Diet in Renal Disease [MDRD] formula)
• One or more severe renal artery stenoses by any of the following pathways:

a. Angiographic: greater than or equal to 60% and less than 100% by renal angiogram OR b. Duplex: systolic velocity of greater than 300 cm/sec OR c. Core Lab approved Magnetic Resonance Angiogram (MRA) (refer to the protocol for specific criteria) demonstrating stenosis greater than 80% OR stenosis greater than 70% with spin dephasing on 3D phase contrast MRA OR stenosis greater than 70% and two of the following: i. Ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Ischemic kidney enhances less on arterial phase iii. Ischemic kidney has delayed Gd excretion iv. Ischemic kidney hyper-concentrates the urine v. 2-D phase contrast flow waveform shows delayed systolic peak vi. Post-stenotic dilatation d. Clinical index of suspicion combined with a Core Lab approved Computed Tomography Angiography (CTA) demonstrating Stenosis is greater than 80% by visual assessment on high quality CTA Stenosis is greater than 70% on CTA by visual assessment and there are two of the following i. The length of the ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Reduced cortical thickness of ischemic kidney iii. Less cortical enhancement of ischemic kidney on arterial phase iv. Post-stenotic dilatation

EXCLUSION CRITERIA

• Unable to provide informed consent
• Unable or willing to comply with study protocol or procedures
• Must be greater than 18 years of age
• Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization
• Pregnancy or unknown pregnancy status in female of childbearing potential
• Participation in any drug or device trial during the study period, unless approved by the Steering Committee
• Prior enrollment in the CORAL study
• History of stroke within 6 months, if associated with a residual neurologic deficit*
• Any major surgery, major trauma, revascularization procedure, unstable angina, or myocardial infarction 30 days prior to study entry*
• Any planned major surgery or revascularization procedure, outside of the randomly allocated renal stenting indicated by the protocol, after randomization*
• Hospitalization for heart failure within 30 days*
• Comorbid condition causing life expectancy of less than or equal to 3 years*
• Allergic reaction to intravascular contrast, not amenable to pre-treatment
• Allergy to stainless steel
• Allergy to all of the following: aspirin, clopidogrel, ticlopidine
• Known untreated aneurysm of the abdominal aorta greater than 5.0 cm.*
• Previous kidney transplant
• a. Stenosis of greater than 50% of a previously treated revascularized renal artery OR b. Treatment of any renal artery stenosis within the past 9 months (roll-in patients can have prior treatment on the contralateral side)
• Kidney size less than 7 cm. supplied by target vessel
• Hydronephrosis, nephritis or other known cause of renal insufficiency, not due to large vessel renal artery stenosis
• Visualized stenosis of only an accessory renal artery supplying greater than 1/2 of the ipsilateral renal parenchyma, without stenosis in a dominant renal artery
• Local lab serum Cr greater than 4.0 mg/dl on the day of randomization*
• Presence of a renal artery stenosis not amenable for treatment with a stent, known to be present prior to randomization
• The index lesion cannot be treated with a single stent (i.e. greater than 18 mm. in length)
• The placement of a stent will necessitate coverin