DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications

Kalos Medical

Status

Enrolling

Conditions

Hypertension

Cardiovascular Diseases

Vascular Diseases

Treatments

Device: Renal Denervation

Study type

Interventional

Funder types

Industry

Identifiers

NCT04307836

DN_P101

Details and patient eligibility

About

The objective of this study is to show that the safety and efficacy of renal denervation using DENEX, are superior to those of control group for the patients with hypertension on no or 1 to 3 antihypertensive medications.

Full description

DENEX system developed by Handok Kalos Medical Inc. is a renal denervation system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. It was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.

Enrollment

140 estimated patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject aged 19 to 75 years old
Subject should maintain the 0 to 3 antihypertensive medications of different classes, ACE-I, ARB, beta blocker, CCB or diuretics, without change for at least 4 weeks of run-in period between primary screening and secondary screening and for at least 3 months after the procedure
Subject with 140 mmHg ≤ average office SBP < 180 mmHg and 90 mmHg ≤ office DBP < 120 mmHg at primary and secondary screening
Subject with 135 mmHg ≤ average daytime ambulatory SBP <170 mmHg and 85 mmHg ≤ average daytime ambulatory DBP < 105 mmHg at secondary screening after the run-in period for at least 4 weeks

Exclusion criteria

Subject with the anatomical findings in kidney or renal artery which preclude renal denervation
Subject with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
Subject with eGFR less than 40mL/min/1.73㎡
Subject with a brachial circumference greater than 42 cm.
Subject with secondary hypertension (except for sleep apnea patients)
Subject with a medical history of cerebrovascular disease or severe cardiovascular disease within 12 months prior to obtaining the consent or patients newly diagnosed with such diseases before enrollment.
Subject rehospitalized two or more times for hypertensive crisis within 12 months prior to obtaining consent or hospitalized for hypertensive crisis within three months prior to obtaining consent.
Subject with chronic oxygen therapy or mechanical ventilation (except for sleep apnea)
Subject with primary pulmonary hypertension