Treatment of Resistant Hypertension by Renal Denervation in China

• Have provided written informed consent
• Are ≥ 18 years and ≤ 75 years of age
• Have a SBP /DBP ≥ 160/90 mm Hg based on an average of three office-based blood pressure readings (seated) measured according to the protocol (≥ 150 mmHg in subjects with Type 2 diabetes)
• On a stable medication regimen with ≥ 3 anti-hypertensive drugs (one of medications should be a diuretic, unless subject has a documented intolerance to diuretics) at maximally tolerated doses and have had no changes to the medication regimen two (2) weeks prior to enrollment
• With a eGFR ≥ 40 ml/min per 1.73m²
• Are willing and able to comply with all study procedures
• With a main renal artery diameter of ≥ 3.5 mm and ≤ 7.0 mm for each of their kidneys
• With a main renal artery without significant stenosis (stenosis defined as \< 30%)
• With a renal artery length of ≥ 15 mm

Exclusion Criteria:

• With secondary hypertension
• With Type I Diabetes Mellitus
• Are contraindicated for intravascular contrast material
• Are contraindicated for anticoagulation medications (heparin, aspirin, Angiomax, etc.), analgesic medications (morphine, fentanyl, etc.), anxiolytic medications (alprazolam, lorazepam, diazepam, etc.) or other medications required for an interventional procedure
• With known bleeding or hyper-coagulation disorders
• Have experienced a myocardial infarction, unstable angina pectoris, uncompensated heart failure, or a cerebrovascular accident within six (6) months prior to the screening visit, or have widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques
• Have planned percutaneous vascular or surgical intervention for any reason within the next 6 months
• Have hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
• Have an implantable cardioverter defibrillator (ICD) or pacemaker or with a clinically significant abnormal electrocardiogram at time of screening
• Have any serious medical condition, which in the opinion of the investigator, may adversely affect subject safety or the efficacy of the procedure in the study (i.e., subjects with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders)
• Are pregnant, nursing or planning to become pregnant or who are currently taking estrogen or any estrogen-like compound (female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to the procedure)
• Have a known, unresolved history of drug use or alcohol abuse/dependency
• Are currently enrolled in any investigational study wherein subject participation has not been completed
• For any reason, may not be able to understand or comply with instructions
• With only one kidney
• With prior renal denervation procedure
• With prior intervention to right or left renal artery
• With renal artery stenosis as defined by ≥ 30% stenosis confirmed by angiography with two (2) orthogonal views with selective catheterization
• With iliac stenosis requiring intervention at time of procedure and/or within the next six (6) months
• With severe femoral, renal, iliac or aortic calcification that may cause a potential complication at the time of the procedure
• The physician is unable to cannulate the renal artery
• The physician is unable to access the femoral artery by percutaneous means