DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study

Kalos Medical

Status: Completed

Conditions: Uncontrolled Hypertension

Treatments: Device: Renal denervation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04248530

DN_C101

Details and patient eligibility

About

The study is the multicenter pilot study to obtain an assessment of the safety of renal denervation in the patients with uncontrolled hypertension on standard medical therapy in Korea.

Full description

DENEX system developed by Handok Kalos Medical Inc. is a renal nerve blocking 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: 16 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Individual is ≥ 20 years of age at time of consent
2. Individual has office systolic blood pressure (SBP) of ≥ 150 mmHg
3. Individual has daytime 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP of ≥ 140 mmHg
4. Individual maintains the following 3 antihypertensive medications: thiazide-type diuretic, calcium-channel blocker, and angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (for at least 6 weeks before the screening visit) that is expected to be maintained without changes for at least 6 months.

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Renal denervation therapy group

Experimental group

Description:

The subject treated by renal denervation by using DENEX system.

Treatment:

Device: Renal denervation