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DENEX Renal Denervation in Patients With Hypertension on no Antihypertensive Medications

NCT04535050 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-03-20

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Renal denervation

Renal Denervation: DENEX system

PROCEDURE

Renal angiography

Renal angiography

Sponsors & Collaborators

  • Kalos Medical

    lead INDUSTRY

Principal Investigators

  • Konstantinos Tsioufis, Professor · National and Kapodistrian University of Athens, Greece

  • Felix Mahfoud, Professor · Saarland University Hospital, Homburg

  • Massimo Volpe, Professor · University of Roma La Sapienza

  • Jacek Kadziela, Professor · Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2023-12-30
Completion
2026-04-15

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04535050 on ClinicalTrials.gov