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

General Inclusion Criteria:

1. Age ≥ 18 at the time of informed consent.

2. 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).

3. 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.

4. 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.

5. Subject must have documented clinical evidence to support likelihood of angiographic
findings > 80% whether it is DUS, CTa, MRa or other medical evidence.

6. 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:

1. 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 > 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 < 0.8 may be
enrolled.

2. Renal pole-to-pole length > 8cm (per visual estimate).

3. Target lesion length ≤ 16mm per vessel (per visual estimate).

4. Renal artery vessel diameter ≥ 5.0mm and ≤ 7.0mm (per visual estimate).

5. Lesion originating ≤ 15mm of the renal ostium.

General Exclusion Criteria:

1. Subject's estimated life expectancy is < 12 months.

2. Subject has a history of transplanted kidney(s), has had another recent organ
transplant or polycystic kidney disease.

3. Subject with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73 m2

4. Subject has a history of bleeding diathesis or coagulopathy or refuses blood
transfusions.

5. Subject has a known contraindication to heparin, aspirin, thienopyridine, other
anti-coagulant/antithrombotic therapies, contrast media, stainless steel, and/or
polytetrafluoroethylene (PTFE).

6. Subject has had a previous renal bypass operation, a bypass is planned, or the
target lesion is located within or beyond a bypass graft.

7. Subject has received a thrombolytic agent within the past 30 days.

8. Subject has documented acute pulmonary edema or systolic heart failure with ejection
fraction < 30% and/or hospitalization requiring intubation and ventilation support
for this diagnosis within the previous 90 days or hypertensive emergencies defined
as resulting in organ damage.

9. Concurrent enrollment in any investigational trial wherein subject's participation
has not been completed.

10. Subject has had a planned or anticipated cardiovascular surgical or interventional
procedure outside of the affected renal artery (including, but not limited to,
aortic, renal, cardiac, carotid, femoro-popliteal, and below the knee) within 30
days prior to the index procedure and prior to completion of the 30 day follow-up.

11. Subject has suffered a stroke or Transient Ischemic Attack (TIA) in the past 3
months.

12. Subject is pregnant, lactating, or is of child-bearing potential and plans to become
pregnant during the follow-up trial period.

13. Subject with significant valvular disease.

14. Subject with known significant proteinuria > 2+ or > 2.0gm/d.

15. 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.

16. Subject with active sepsis.

17. Subject with serum creatinine ≥ 3.0mg/dL.

18. Subject with NYHA Class IV at the time of enrollment.

19. Subject is on hemodialysis.

20. Subject has a history of renal aneurysm.

21. Subject with cardiogenic shock.

22. Subject with cardiomyopathy.

23. Subject has an uncontrolled concurrent illness, including but not limited to ongoing
or active infection or active autoimmune disease requiring immunosuppressive
therapy.

24. 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:

1. The planned site of intervention is totally occluded or has an anatomic
configuration likely to prohibit adequate dilatation, and/or passage or implantation
of the investigational device.

2. Subject has multiple ipsilateral lesions of the target renal artery that cannot be
covered by a single stent.

3. There is a previously implanted stent in the target vessel or there is a previously
implanted stent in the contralateral vessel < one year.

4. Subject has fibromuscular dysplasia, in renal artery and/or other vascular bed.

5. The target lesion site is associated with a thrombus.

6. Target lesion treated with laser atherectomy, directional atherectomy or other
adjuncts to percutaneous balloon angioplasty (PTA).

7. Subject has a critical stenotic (> 70%) small accessory renal artery.

8. Subject has an abdominal aortic aneurysm > 4.0cm in diameter or a severe
atherosclerotic aorta.

9. Main renal artery length ≤ 15mm precluding the safe deployment of a covered renal
stent.

10. Any lesion that would include blocking of renal artery side branch.

11. Renal artery stenosis due to dissection of renal artery: spontaneous or traumatic.