Patient description: An 82-year-old woman comes to the emergency department because of chest pain and shortness of breath after being awakened in the morning by stabbing substernal chest pain radiating to the left shoulder and jaw. The patient had hypertension, renal-artery stenosis with chronic renal insufficiency, hypercholesterolemia, osteoporosis and dementia. Blood pressure was 199/108 mm Hg, respiratory rate 18 bpm, oxygen saturation 98% on ambient air. The heart sounds were rapid and with no murmurs. CK-MB was 10.9 ng/ml, CK was 89 U/l, CK index was 12.2% and Troponin T was 0.40 ng/ml. An EKG showed sinus regular tachycardia of 119 bpm, with ST-segment elevations up to 3 mm in V1, V2, and V3. A chest radiograph showed low lung volumes and right basilar subsegmental atelectasis. Coronary angiography showed no stenosis or clinically significant disease. Left ventriculography revealed akinesis of the anterior wall, hypokinesis of the apical and distal inferior walls, and compensatory hyperkinesis of the basal anterior and basal inferior walls. A transthoracic echocardiogram showed severe segmental left ventricular dysfunction involving the septum, anteroseptal territory, and apex. The overall left ventricular systolic function was mildly impaired and there was mild mitral regurgitation.

Clinical trial eligibility criteria: eligible ages (years): 18.0-999.0,  Renal Artery Stenosis Hypertension, Renovascular General Age ≥ 18 at the time of informed consent Subject or subject's legal representative have been informed of the nature of the trial, agrees to participate, and has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) Subjects that have bilateral kidneys or a solitary functioning kidney with Renal Artery Stenosis in at least one kidney and an average Systolic Blood Pressure (SBP) ≥ 155mmHg Subject has a history of maximum tolerable dose of ≥ 3 anti-hypertensive medications of different classes, one of which must be a diuretic (for at least two weeks prior to Medical Documentation Screening period) a. A documented history for a minimum of 3 months showing reasonable and aggressive efforts to manage hypertension prior to consent. This must the use of a broad variety of medications that have been used and failed or not tolerated Subject must have documented clinical evidence to support likelihood of angiographic findings > 80% whether it is DUS, CTa, MRa or other medical evidence New York Heart Association (NYHA) class I, II, or III the time of trial enrollment NOTE: When a subject has bilateral Renal Artery Stenosis both of which require stenting, it is recommended to treat both kidneys with an iCAST™ RX Stent System during the index procedure. In the event that a subject needs a renal stenting procedure staged for renal protection, it is important that the Investigator treats the second renal artery with an iCAST™ RX Stent System after 30 days of the index procedure. If subjects with bilateral stenosis have only one lesion that meets protocol that lesion should be treated per protocol. The recommendation is to NOT treat the second non-qualifying lesion, however if the operator feels strongly it is indicated, then they should treat per standard of care after 30-days post index procedure in order to comply with #10 Subjects with flash pulmonary edema are allowed into the trial should they meet all other and  Angiographic Anatomic Angiographic diameter renal artery stenosis ≥ 80% involving unilateral or bilateral renal arteries a. The degree of percent diameter stenosis for all lesions intended to be treated, must be confirmed via one of the following methods: i. Manual or automated measurement with calipers ii. Measured Flow Fraction Reserve (FFR) < 0.8 using a pressure wire iii. Measured translesional peak pressure gradient of > 21mmHg after induced hyperemia via dopamine or papaverine using a 4Fr or less catheter or pressure wire b. Subjects with 60-79% angiographic stenosis who have confirmed FFR < 0.8 may be enrolled Renal pole-to-pole length > 8cm (per visual estimate) Target lesion length ≤ 16mm per vessel (per visual estimate) Renal artery vessel diameter ≥ 5.0mm and ≤ 7.0mm (per visual estimate) Lesion originating ≤ 15mm of the renal ostium General Subject's estimated life expectancy is < 12 months