NCT04535050

DENEX Renal Denervation in Patients With Hypertension on no Antihypertensive Medications

A Prospective, Multicenter, Sham-controlled, Single-blinded, Randomized, Pilot Study to Evaluate the Safety and Effectiveness of DENEX Renal Denervation System in Patients With Uncontrolled Hypertension Not Treated With Anti-HTN Medication

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kalos Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and effectiveness of renal denervation using DENEX System in patients with hypertension without antihypertensive medication, compared with the sham group.

Detailed description

DENEX system developed by 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.

Conditions

• Hypertension
• Vascular Diseases
• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Renal denervation	Renal Denervation: DENEX system
PROCEDURE	Renal angiography	Renal angiography

Timeline

• Start date: 2022-10-20
• Primary completion: 2023-12-30
• Completion: 2026-04-15
• First posted: 2020-09-01
• Last updated: 2023-03-20

Locations

1 site across 1 country: Greece