Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions
Condition: Atherosclerosis; Cardiovascular Diseases; Hypertension, Renovascular; Renal Artery Obstruction
MeSH terms: Renal Artery Obstruction; Hypertension, Renovascular; Cardiovascular Diseases; Atherosclerosis
Intervention: Atacand/HCT, Caduet; GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting)
Intervention description: Atacand/HCT and caduet or optimal medical therapy for hypertension; Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device
Intervention MeSH terms: Candesartan cilexetil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 947.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare medical therapy plus stenting of hemodynamically significant renal
      artery stenoses versus medical therapy alone in patients with systolic hypertension and renal
      artery stenosis.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          1. Either

               1. Documented history of hypertension on two or more anti-hypertensive medications
                  OR

               2. 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)

          2. 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:

          1. Unable to provide informed consent

          2. Unable or willing to comply with study protocol or procedures

          3. Must be greater than 18 years of age

          4. Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be
             present prior to randomization

          5. Pregnancy or unknown pregnancy status in female of childbearing potential

          6. Participation in any drug or device trial during the study period, unless approved by
             the Steering Committee

          7. Prior enrollment in the CORAL study

          8. History of stroke within 6 months, if associated with a residual neurologic deficit*

          9. Any major surgery, major trauma, revascularization procedure, unstable angina, or
             myocardial infarction 30 days prior to study entry*

         10. Any planned major surgery or revascularization procedure, outside of the randomly
             allocated renal stenting indicated by the protocol, after randomization*

         11. Hospitalization for heart failure within 30 days*

         12. Comorbid condition causing life expectancy of less than or equal to 3 years*

         13. Allergic reaction to intravascular contrast, not amenable to pre-treatment

         14. Allergy to stainless steel

         15. Allergy to all of the following: aspirin, clopidogrel, ticlopidine

         16. Known untreated aneurysm of the abdominal aorta greater than 5.0 cm.*

         17. Previous kidney transplant

         18. 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)

         19. Kidney size less than 7 cm. supplied by target vessel

         20. Hydronephrosis, nephritis or other known cause of renal insufficiency, not due to
             large vessel renal artery stenosis

         21. 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

         22. Local lab serum Cr greater than 4.0 mg/dl on the day of randomization*

         23. Presence of a renal artery stenosis not amenable for treatment with a stent, known to
             be present prior to randomization

               1. The index lesion cannot be treated with a single stent (i.e. greater than 18 mm.
                  in length)

               2. The placement of a stent will necessitate covering a renal artery branch renal
                  artery with a stent

               3. The stenosis is in an artery less than 3.5 mm. in diameter

               4. The stenosis involves a segmental renal artery branch

         24. Abrupt vessel closure or dissection after diagnostic angiography [NOTE: Patients with
             abrupt vessel closure or dissection as a result of diagnostic angiography will not be
             randomized but will undergo stent revascularization, receive optimal medical therapy
             and will be followed for the full study period] *Roll-in patients do not need to meet
             these inclusion/exclusion criteria