Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Benefit of STent Placement and Blood Pressure and Lipid-Lowering for the Prevention of Progression of Renal Dysfunction Caused by Atherosclerotic Ostial Stenosis of the Renal Artery (STAR)
Brief Summary: Background:

Atherosclerotic renal artery stenosis (ARAS) is associated with progressive loss of renal function and is one of the most important causes of renal failure in the elderly. Current treatment includes restoration of the renal arterial lumen by endovascular stent placement. However, this treatment only affects damage caused by ARAS due to the stenosis and ensuing post-stenotic ischemia. ARAS patients have severe general vascular disease. Atherosclerosis and hypertension can also damage the kidney parenchyma causing renal failure. Medical treatment focuses on the latter. Lipidlowering drugs (statins) could reduce renal failure progression and could reduce the overall high cardiovascular risk. The additional effect on preserving renal function of stent placement as compared to medical therapy alone is unknown. Therefore, the STAR-study aims to compare the effects of renal artery stent placement together with medication vs. medication alone on renal function in ARAS patients.

Method:

Patients with an ARAS of ≥50% and renal failure (creatinine (Cr) clearance \<80 mL/min/1.73 m2) are randomly assigned to stent placement with medication or to medication alone. Medication consists of statins, anti-hypertensive drugs and antiplatelet therapy. Patients are followed for 2 yrs with extended follow-up to 5 yrs. The primary outcome of this study is a reduction in Cr clearance \>20% compared to baseline. This trial will include 140 patients.


Options:
A: 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
B: Inclusion Criteria:

* Systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg despite at least 3 antihypertensive medications
* Systolic blood pressure \>140 mmHg and/or diastolic blood pressure \> 90 mmHg on two antihypertensives with: a rise in creatinine \> 20% after initiation of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB); the sudden onset of hypertension occurring after age 55; hypokalemia or the presence of an abdominal bruit; a history of flash pulmonary edema; or any three of: peripheral vascular disease, coronary artery disease, cerebrovascular disease, smoking, hyperlipidemia, diabetes or male gender.

Exclusion Criteria:

* Serum creatinine \> 220 umol/L or estimated glomerular filtration rate (GFR) by Cockroft-Gault equation \< 20 ml/min
* Patients who are unwilling or unable to give informed consent
* Known contraindication to renal revascularization such as anaphylactic allergy to contrast dye
* An abdominal aortic aneurysm requiring surgery
* A single functioning kidney; a total occlusion of the renal artery or renal artery stenosis due to fibromuscular dysplasia.
* Previous revascularization
C: Inclusion Criteria:

* Age \>18 years
* Ostial atherosclerotic renal artery stenosis ≥50% on CTA, MRA or intra-arterial angiography
* Estimated creatinine clearance \<80 ml/min/1.73m2 according to the Cockcroft and Gault formula, on two occasions within one month

Exclusion Criteria:

* Declined informed consent
* Proven cholesterol embolisation at previous interventions
* Renal artery diameter \<4mm
* Estimated creatinine-clearance \<15ml/min/1.73m2
* Diabetes Mellitus with proteinuria \>3g/24h
* Any known cause of renal failure other than ischemic nephropathy
* Pulmonary oedema in the presence of bilateral renovascular disease in combination with intolerance of ACE-inhibitors/ Angiotensin-II antagonists defined as a fall of estimated creatinine clearance of \>20%
* Malignant hypertension (fundus grade III/IV)
* Myocardial infarction or CVA \<3 months before planned date of inclusion
* Contra-indication for the use of atorvastatin
D: Inclusion Criteria:

* Age ≥ 18 years
* Informed consent signed by patient (and/or legal guardian),
* Hemodynamically relevant de novo unilateral or bilateral atherosclerotic renal artery diameter stenosis RAS (≥ 70%)
* Estimated GFR \> 10 ml/min calculated using the abbreviated Modification of Diet in Renal Disease (MDRD) Study equation,
* Patients presenting mild, moderate or severe hypertension (defined according to the WHO guidelines) and/or renal dysfunction,
* Target lesion must be completely coverable by one study stent,
* Total target lesion length estimated to be less than 19 mm,
* Target lesion accessible to direct stenting or, after pre-dilation, is likely to sufficiently benefit from stenting (at the discretion of the investigator),
* Renal reference vessel diameter (RVD) of ≥ 4.0 mm and \< 7.0 mm based on visual estimation,
* Willingness to comply with all the specified follow-up evaluations.

Exclusion Criteria:

* Estimated GFR ≤ 10 ml/min,
* Renal atrophy or kidney length \< 7cm (referring to kidney with target lesion),
* Patient not eligible for PTRAS,
* Patient not eligible for stenting,
* Target lesion occlusion,
* Target lesion and/or target vessel proximal to the target lesion is severely calcified,
* Treatment of branch lesion required,
* Fresh thrombus or embolic lesion
* Need for embolic protection in previous or planned PTRAS,
* Clotting disorders,
* INR \> 2.5 before the intervention,
* Patient presents fibromuscular dysplasia,
* Prior revascularization of target lesion,
* History of target vessel revascularization within the last six months,
* Angiographic restenosis of any segment of the target vessel that has undergone prior percutaneous intervention,
* Any thrombolytic therapy procedure within 72 hours prior to planned study procedure
* Active peptic ulcer or gastro intestinal bleeding,
* Active inflammation of the kidney interfering with diagnosis and treatment of RAS (e.g. glomerulonephritis, aortitis, vasculitis),
* Radiation damage of the kidney,
* Renal disease associated with aortic aneurysm i.e. diameter of the aorta \> 40 mm,
* Chronic renal replacement therapy,
* Life expectancy \< 1 year,
* Co-morbid conditions limiting participation and follow-up
* Patient currently participating in another trial possibly influencing the safety of the patient and/or the outcomes of the study,
* Pregnancy/Planned pregnancy/Childbearing potential without sufficient measures to prevent pregnancy as judged by the investigator,
* Known allergy to contrast medium that cannot be adequately controlled with pre-medication,
* Known intolerance against acetylic-salicylic acid (ASA), heparin, clopidogrel and ticlopidin, cobalt-chromium,
* Metformin intake not stopped at least 48 hours before the intervention

Answer: C