FlashPoint Renal Denervation Under Columbus 3D Mapping System Guidance for Treating Hypertension

Prior treatment

• During the screening and lead-in period, the patient used antihypertensive drugs other than the standard antihypertensive drugs prescribed in this study protocol;

Other illness

• Renal artery anatomy failures include:
  • Renal artery diameter \<4mm or treatment length \<20mm;
  • Renal artery stenosis \>50% or renal aneurysm on either side;
  • A history of renal artery intervention, including balloon angioplasty or stenting or RDN;
• History of hospitalization for hypertensive crisis in the past year;
• Nocturnal sleep apnea syndrome requires mechanical ventilation (such as tracheostomy);
• Those who have or are currently suffering from the following diseases or conditions:
  • Primary pulmonary hypertension (moderate to severe);
  • Type I diabetes;
  • History of any cerebrovascular events (eg, stroke, transient cerebral ischemic event, cerebrovascular accident) within 3 months;
  • History of any serious cardiovascular event within 3 months (eg, myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV), unstable angina attack);
  • Factors that interfere with blood pressure measurement in any case (eg, patients with severe peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, severe anemia);
  • Arranged or planned surgery or cardiovascular intervention within the next 6 months;
  • Patients with malignant tumors and end-stage diseases who survival period is less than 1year;
• Patients with secondary hypertension.

Lab values

• Glomerular filtration rate (eGFR) \<45mL/min/1.73m2 (MDRD formula);

Other

• Patients who are deemed inappropriate to participate in this trial by other investigators.

• Males or females aged ≥18 and ≤70 (not pregnant, breastfeeding, and have no reproductive plan within one year);
• Patients with essential hypertension, antihypertensive drug intolerance, and willing to undergo surgical treatment;
• Ambulatory blood pressure measurement 24-hour average systolic blood pressure ≥130mmHg or daytime ≥135mmHg, and pulse pressure difference \<80 mmHg;
• A history of using antihypertensive medication within six months and blood pressure is still uncontrollable; standardized medication (at least two drugs) for at least 28 days before enrollment, and medication compliance ≥ 80%, office systolic blood pressure (OSBP) ) ≥ 150 mmHg and \<180 mmHg, diastolic blood pressure (DBP) ≥ 90 mmHg;
• The patients agree to participate in this clinical trial and sign the informed consent form, agreeing to follow-up evaluation under the requirements of the verification protocol.