Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN — RADIUS-HTN  

Uncontrolled Hypertension Clinical Trial

Official title: Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN:Non Inferiority Study Comparing Safety and Efficacy of Radio Frequency Renal Denervation Using Iberis Renal Denervation System Via Radial Access Compared With Femoral

Status Not yet recruiting

Clinical Trial Summary

Non-inferiority, prospective, multi-center, post-market, randomized 1:1 study 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.

Clinical Trial Description

Non-inferiority, prospective, multi-center, post-market, randomized 1:1 study. 90 patients with uncontrolled hypertension treated with 2 to 5 anti-hypertensive drugs including one Angiotensin Receptor Blocker (ARB) associated to one diuretic or Calcium Channel blocker.

12 sites will be selected in 3 countries (France, Germany and Monaco) to enroll 90 patients.

A parallel registry on radial approach only (patients who cannot be treated by femoral ) will have the same follow up.

Each patients will have two follow-ups:

• at 3 months (90+14)

• at 6 months (180+30)

The expected duration of the inclusion is 15 months. The estimated duration of the Study is 26 months. ;

Related Conditions & MeSH terms

• Hypertension
• Renal Denervation
• TransRadial
• Uncontrolled Hypertension

• NCT number: NCT05234788
• Study type: Interventional
• Source: Shanghai AngioCare Medical
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Completion date: July 1, 2023