Please select the eligibility criteria that correspond to the clinical trial below.
Title: Endovascular Treatment Versus Optimal Medical Treatment of Atherosclerotic Renal Artery for Preserving Renal Function of the Ischemic Kidney.
Brief Summary: Renal atherosclerotic stenosis (RAS) is a prevalent cause of secondary hypertension (HT). Since there are still uncertainties as to whether and in what patients revascularization by means of percutaneous renal angioplasty (PTRAS) should be pursued, we designed a study exploiting an optimized patient selection strategy and using hard experimental endpoints to unravel these uncertainties.

Primary objective: to determine if revascularization by means of PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate in the ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan.

Secondary objectives: to determine if the two treatments are equivalent in lowering blood pressure (BP), preserving overall renal function and regressing damage in the target organs of hypertension.

Design: prospective multicenter randomized, unblinded two-arm study.

Eligible patients will have clinical and/or radiological evidence of unilateral or bilateral RAS, defined by stenosis of the proximal portion of the renal artery and its main bifurcations at angioCT. Duplex scan will exclude nephroangiosclerosis as the latter could bias the assessment of the outcome of revascularization.

Inclusion criteria. RAS affecting the main renal artery or its major branches at angio-CT either \> 70% or, if \< 70 with post-stenotic dilatation.

Renal function will be assessed with 99mTc-DTPA renal scintigraphy.

Sample size (30 patients per arm) was calculated to have a 90% power to detect a difference in means of GFR in the vascularized (or control untreated kidney) of 7.5 ml/min.

Arms

1. Revascularization: digital scan angiography and PTA with stenting of the renal artery at the ostium or at truncular level, plus optimal medical therapy.
2. Medical therapy: the drug regimen that had been optimized during the run-in period.

Experimental endpoints:

The absolute value of GFR assessed by 99TcDTPA in the ischemic kidney will be used as quantitative variable and compared between groups at each time point. A categorical definition of kidney loss, defined as a GFR in the ischemic kidney of \< 5 ml/min, will be also used and the rate of achievement of such endpoint will be compared.

Duration: 5 years.


Options:
A: Inclusion Criteria:

* RAS affecting the main renal artery or its major branches at angio-CT either \> 70% or, if \< 70 with post-stenotic dilatation AND
* resistance index (RI) \< 0.55 or \> 0.55 but \< 0.80 with evidence of intrarenal heterogeneity of the RI as revealed by a CV \> 10% in the RI across the upper, mid and lower third of each kidney.

Exclusion Criteria:

* refusal to participate to study,
* previous endovascular or surgical treatment of RAS,
* fibromuscular RAS,
* planned or actual pregnancy, or childbearing potential without measures adequate to prevent pregnancy,
* life expectancy \< 2 years,
* patient currently participating in another trial possibly influencing the safety of the patient and/or the outcomes of the study,
* co-morbid conditions limiting participation and follow-up.
B: 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
C: 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
D: 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

Answer: A