The HERCULES Trial - A Safety and Effectiveness Study of the Herculink Elite Renal Stent to Treat Renal Artery Stenosis

General Clinical Inclusion Criteria:

• Subject is ≥18 years of age.
• Subject and subject's physician agree to have the subject return for all required contact following study enrollment.
• Subject has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
• Subject is a candidate for renal artery stenting.
• Subject has uncontrolled systolic hypertension (systolic Blood Pressure[SBP] ≥140 mmHg), or uncontrolled diastolic hypertension (diastolic BP [DBP] ≥90 mmHg), or a combination of both in the presence of at least two (2) or more antihypertensive medications.
• Subject has a baseline serum Creatinine of 2.5 mg/dl.
• Subject has any immunosuppressive disorder, access site infection, or acute systemic infection due to any cause.
• Subject has other medical illnesses (e.g., cancer, end-stage congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation, or is associated with a life expectancy of less than three years.
• Subject has any medical illnesses that would make them unlikely to respond to treatment (e.g., sickle cell nephropathy/sickle cell disease, scleroderma, arteriolar nephrosclerosis, hemolytic-uremic syndrome and vasculitis).
• Subject has had a Q-wave MI within 30 days before index procedure.
• Subject has had a stroke or TIA within 30 days before index procedure.
• Subject has a history of congestive heart failure and has a previously documented LVEF ≤25%.
• Subject is normotensive or has adequate control of hypertension (SBP 15 mm in length.
• Requirement for >1 stent to treat full length of lesion and dissection.
• Target lesion has a total (100%) occlusion.
• Evidence of thrombus or mobile filling defect in the target lesion or vessel.
• Subject has co-existing aneurysmal or occlusive disease of the abdominal aorta requiring surgical reconstruction during the follow-up period.
• Target lesion is non-atherosclerotic (fibromuscular dysplasia).
• Subject artery has patent bifurcation within 10 mm of ostium that might be covered by placement of a stent.
• The target lesion is within the artery of a solitary functioning kidney or, the subject has a contralateral totally occluded renal artery.
• For planned treatment of bilateral lesions: the more critical lesion, i.e. lesion with the greater stenosis (which should be treated first), is either treated unsuccessfully or requires a bailout procedure. (NOTE: Less critical lesion is excluded at this point.)
• Subject has any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe.
• The target lesion is densely calcified and will not yield during balloon dilation.
• Subject has had recent change in renal function after unrelated catheter or surgical procedure with the clinical stigmata of atheroemboli syndrome (i.e., livedo reticularis: non-occlusive mesenteric ischemia; digital gangrene; progressive renal insufficiency without other identifiable etiology).
• Subject has an accessory renal artery that has >50% stenosis. Accessory renal arteries may not be stented as part of this study.