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

General Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years old 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 IRB/EC approved ICF.
3. Subject understands and can comply with the duration of the trial and its follow-up visit requirements.

4. Subjects that have one of the following:

   1. Subject has bilateral kidneys but only unilateral renal artery stenosis and an average SBP ≥ 155mmHg and ≤ 180mmHg.
   2. Subject has solitary kidney with renal artery stenosis and an average SBP ≥ 155mmHg.
   3. Subject has bilateral kidney with bilateral renal artery stenosis and an average SBP ≥ 155mmHg.

5. Subject has a history of maximum tolerable dose of ≥ 3 anti-hypertensive medications (for at least two weeks prior to Medical Documentation Screening period)

   1. Subject must be on ≥ 3 medications of different anti-hypertensive medication classes including:

      • A diuretic
      • An angiotensin converting enzyme inhibitor (ACE) or an angiotensin receptor blocking agent (ARB)
      • A beta blocker or calcium channel blocker
   2. Subject has a focused hypertension medical history (capturing at least three months prior to screening) that documents reasonable and aggressive efforts were previously made to manage hypertension via a broad variety of medications that have been tried and failed.
6. Core laboratory adjudicated DUS indicating renal artery stenosis ≥ 60% within 12 weeks prior to enrollment

7. NYHA class I, II, or III the time of trial enrollment.

   • Subjects with unilateral and bilateral stenosis without tolerance of ACE and 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 renal artery stenosis ≥ 80% involving unilateral or bilateral renal arteries.

   a. The degree of stenosis must be confirmed via one of the following methods:

   • Manual or automated measurement with calipers

   • Measured Fraction Flow Reserve (FFR)

     • Subjects with 60-79% stenosis with FFR < 0.8 may be enrolled.
   • Measured translesional pressure gradient of > 21mmHg after induced hyperemia.
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) or polycystic kidney disease.
3. Subject with estimated eGFR ≤ 25mL/min/1.73m2
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 PTFE.
6. Subject has had a previous renal bypass operation or a bypass is planned.
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. Current enrollment in any investigational trial wherein subject's participation has not been completed.
10. Subject has had a cardiovascular surgical or cardiovascular interventional procedure (including, but not limited to, aortic, renal, cardiac, carotid, femoro-popliteal, and below the knee) within 30 days prior to the index procedure.
11. Subject has 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.
12. Subject has suffered a stroke or Transient Ischemic Attack (TIA) in the past 3 months.
13. Subject is pregnant, lactating, or is of child-bearing potential and plans to become pregnant during the follow-up trial period.
14. Subject with prior kidney transplant or any other recent organ transplant.
15. Subject with known significant valvular disease.
16. Subject with known significant proteinuria > 2.0gm/d.
17. Subject with known bilateral upper-extremity arterial stenosis that result in spuriously low arm pressures.
18. Subject without the ability to gain reliable blood pressure measurements in one upper extremity.
19. Subject with active sepsis.
20. Subject with lesions located within or beyond a bypass graft.
21. Subject with serum creatinine ≥ 3.0mg/dL.
22. Subject with NYHA Class IV at the time of enrollment.
23. Subject is on hemodialysis.
24. Subject has a history of renal aneurysm.
25. Any subject who, in the opinion of the investigator, would not be a good candidate for enrollment.
26. Subject with cardiogenic shock.
27. Subject with cardiomyopathy.

Angiographic Anatomic Exclusion Criteria:

1. Subject with critical stenosis in a small accessory renal artery.
2. The planned site of intervention is totally occluded.
3. Subject has multiple ipsilateral lesions of the target renal artery that cannot be covered by a single stent.
4. There is a previously implanted stent in the target vessel.
5. There is a previously implanted stent in the contralateral vessel < one year.
6. Subject has fibromuscular dysplasia, in renal artery and/or other vascular bed.
7. The target lesion site is associated with a thrombus.
8. Subject has occluded bilateral iliac arteries and/or extensive peripheral arterial disease which precludes sheath placement and/or wire passage.
9. Inability to cross the target lesion with the guidewire.
10. Target lesion treated with laser atherectomy, directional atherectomy or other adjuncts to PTA.
11. Target vessel has anatomic configuration likely to prohibit adequate dilatation, and/or passage or implantation of the investigational device.
12. Subject has a stenotic (> 70%) accessory renal artery.
13. Subject has an abdominal aortic aneurysm > 4.0cm in diameter.
14. Main renal artery length ≤ 15mm precluding the safe deployment of a covered renal stent.
15. Any lesion that would include blocking of renal artery side branch.
16. Renal artery stenosis due to dissection of renal artery: spontaneous or traumatic.
17. Severe atherosclerotic aorta.