Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension

General Inclusion Criteria:

• 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 include 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 inclusion criteria 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 exclusion criteria #10.

Subjects with flash pulmonary edema are allowed into the trial should they meet all other Inclusion and Exclusion criteria.

Angiographic Anatomic Inclusion Criteria:

• 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) 21 mmHg after induced hyperemia via dopamine or papaverine using a 4 Fr or less catheter or pressure wire.

b. Subjects with 60-79% angiographic stenosis who have confirmed FFR 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 Exclusion Criteria:

• Subject's estimated life expectancy is 2+ or > 2.0gm/d.
• Subject with known bilateral upper-extremity arterial stenosis that result in spuriously low arm pressures or without the ability to gain reliable blood pressure measurements in at least one upper extremity.
• Subject with active sepsis.
• Subject with serum creatinine ≥ 3.0mg/dL.
• Subject with NYHA Class IV at the time of enrollment.
• Subject is on hemodialysis.
• Subject has a history of renal aneurysm.
• Subject with cardiogenic shock.
• Subject with cardiomyopathy.
• Subject has an uncontrolled concurrent illness, including but not limited to ongoing or active infection or active autoimmune disease requiring immunosuppressive therapy.
• Any subject with clinically significant cardiovascular, respiratory, neurologic, hepatic, endocrine, major systematic disease, making implementation or interpretation of the protocol or protocol results difficult or who in the opinion of the investigator would not be a good candidate for enrollment.

Angiographic Anatomic Exclusion Criteria:

• The pl