Patient on anticoagulant therapy that cannot be temporarily withheld for performing catheterization
Patient has a single functioning kidney
Documented thrombocytopenia, clotting disorders or aortic aneurysms
Moribund patient, or patient with comorbidities limiting life expectancy to less than one year
Contraindication to recommended study medications or intravascular contrast material that cannot be adequately controlled with pre-medication
Concurrent enrollment in another trial
Main renal arteries \< 4 mm in lumen diameter or \< 20 mm in length
Aorto-renal angle that prevents a safe cannulation of the renal artery
Severe common femoral artery, common and/or external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the procedure
Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
Any renal artery stenosis \> 50% by visual assessment
Any renal artery aneurysm in either renal artery
A history of prior renal artery balloon angioplasty or stenting (for patients in Cohort A and B only, also a history of prior renal denervation at any time)
Clareo Health | Continued Safety and Performance of the TIVUS System
