DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study

Exclusion Criteria

• •1. Main renal artery contains renal artery stenosis \>50%
• •2. Individual has confirmed anatomical findings in kidneys or renal arteries through CT scan or angiogram
• •3. Undergone prior renal angioplasty
• •4. Main renal arterial vessel for each kidney \<4 and \>8 mm in diameter, or \<20 mm length
• •5. Individual has an Estimated glomerular filtration rate \<45 mL/min/1.73 m2 at screening visit
• •6. Individual has experienced myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 3 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques
• •7. Individual has Hemodynamically or echocardiography significant valvular heart disease
• •8. Individual has secondary hypertension (pheochromocytoma, Cushing syndrome,coarctation of the aorta, renovascular hypertension, primary hyperaldosteronism, or other secondary hypertension)
• •9. Individual has documented primary pulmonary hypertension
• •10. Individual has orthostatic hypotension with symptom
• •11. Individual requires chronic oxygen support for sleep apnea
• •12. Individual is taking chronic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Only, Aspirin is permitted for cardiovascular disease prevention
• •13. Individual has Type 1 diabetes mellitus