CORAL - Peripheral Arterial Disease - Renal

Title: CORAL – Cardiovascular Outcomes in Renal Atherosclerotic Lesions

Study Sponsor: National Institutes of Health Heart, Lung and Blood Institute

Principal Investigator: Alan T. Hirsch, MD

Study Synopsis:   This trial is for patients who have been diagnosed with high blood pressure and a blockage (narrowing) in one or both of the kidney arteries. This condition is called renal artery stenosis or RAS. This trial is designed to determine the following question: does opening a narrowed renal artery by stenting improve survival and other health measures when added to the careful treatment of high blood pressure?

If eligible, you may receive one of the 2 treatments:

1) Renal stenting plus medical therapy 

OR

2) Medical therapy alone

Every patient will be followed for up to 5.5 years. We will be evaluating blood pressure and kidney function throughout the study.

How do I qualify? You must be diagnosed with Hypertension (high blood pressure) on 2 or more blood pressure medications and have a blockage in one or both of your kidney arteries.

Who do I contact for more information?  Holly MacDonald, RN, CCRC

Inclusion Criteria

1. Documented history of hypertension on 2 or more anti-hypertensive medications OR
   Renal dysfunction defined as Stage 3 or greater CKD based on the new NKF classifications (estimated GFR < 60 mL per minute per 1.73 m2 calculated by the modified MDRD formula) *
2. One or more severe renal artery stenoses by any of the following pathways:
   1. Angiographic: ≥ 60% and < 100% by renal angiogram OR
   2. Duplex: systolic velocity of > 300 cm/sec OR
   3. Core lab approved MRA demonstrating:  Stenosis >90% OR Stenosis >75% with spin dephasing on 3D phase contrast MRA OR Stenosis > 75% and two of the following:
      1. Ischemic kidney is > 1 cm smaller than contralateral kidney.
      2. Ischemic kidney enhances less on arterial phase.
      3. Ischemic kidney has delayed Gd excretion.
      4. Ischemic kidney hyper-concentrates the urine.
      5. 2-D phase contrast flow waveform shows delayed systolic peak.

Exclusion Criteria

1. Unable to provide informed consent
2. Unable or unwilling to comply with study protocol or procedures
3. Age <18
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 dictated by this protocol, after randomization*
11. Hospitalization for heart failure within 30 days*
12. Comorbid condition causing life expectancy £ 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 >5.0 cm*
17. Previous kidney transplant
18. Stenosis of > 50% of a previously treated revascularized renal artery or treatment of any renal artery stenosis within the past 9 months 19. Kidney size less than 7 cm supplied by target vessel
19. Hydronephrosis, nephritis or other known cause of renal insufficiency, not due to large vessel renal artery stenosis
20. Visualized stenosis of only an accessory renal artery supplying <1/2 of the ipsilateral renal parenchyma, without stenosis in a dominant renal artery
21. Local lab serum Cr >3.0 mg/dl on the day of randomization*
22. Presence of a renal artery stenosis not amenable for treatment with a stent, known to be present prior to randomization
23. 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.]