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Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN

NCT05234788 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-07-05

No results posted yet for this study

Summary

Non-inferiority, prospective, multi-center, international, post-market, randomized (1:1) clinical trial in patients with uncontrolled hypertension to compare the safety and efficacy of radio frequency renal denervation using Iberis Renal Denervation System via radial access compared with femoral access.

Conditions

Interventions

PROCEDURE

Transfemoral Renal Denervation

Radiofrequency renal denervation using the Iberis Renal Denervation System treated via femoral artery access

PROCEDURE

Transradial Renal Denervation

Radiofrequency renal denervation using the Iberis Renal Denervation System treated via radial artery access

Sponsors & Collaborators

  • Shanghai AngioCare Medical

    lead INDUSTRY

Principal Investigators

  • Felix Mahfoud, MD, MA · University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-08-03
Primary Completion
2025-09-01
Completion
2025-12-01

Countries

  • France
  • Germany
  • Switzerland

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 NCT05234788 on ClinicalTrials.gov