HQ-HTN-K01-02 is a prospective, multicenter, single arm, open label, first-in-human study to evaluate the safety and initial efficacy of HyperQureTM, laparoscopic denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications
Male and female patients aged between 19 and 79 years old
Resistant hypertensive patients on stable regimen of at least 3 antihypertensive medications* for at least 4weeks prior Screening1 and those who are willing to continue existing antihypertensive medications during run- in period and till 3 months after surgery from Screening 1
Patients on at least 3 antihypertensive medications of different classes including diuretics
Office systolic blood pressure (SBP) ≥ 140 mmHg
Those with the following confirmed anatomical findings in the kidney or renal artery that are unsuitable for renal denervation (assessed based on the results of the renal CT angiography of Screening 2)
If there is an atheroma or renal artery stent within 5 mm of the renal denervation site
Presence of stenosis of 30% or more on all of the blood vessels available for renal denervation therapy
When it is deemed impossible to perform denervation on both renal arteries according to the discretion of the investigator