NCT05234788

Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN

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: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shanghai AngioCare Medical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Non-inferiority, prospective, multi-center, international, post-market, randomized (1:1) clinical trial. 90 patients with uncontrolled hypertension treated with 2 to 5 antihypertensive drugs including one angiotensin receptor blocker (ARB) or angiotensin-converting enzyme Inhibitor (ACE-I) in combination with one diuretic or calcium channel blocker will be randomized in a 1:1 ratio to the radial access renal denervation group (intervention) or the femoral access renal denervation group (control). Around 12 sites in 3 European countries (France, Germany and Switzerland) are planned to enroll 90 patients. For patients with a contraindication for the TransFemoral Access (major femoral disease, bilateral femoral vascular prosthesis, extreme obesity), a register is also carried out in parallel with the study. The inclusion and exclusion criteria will be the same except the fact that patients have to be eligible for TransFemoral access, endpoints and data collected will be the same. All patients will be followed per standard of care practice and follow-up visits are scheduled at 3 months (follow-up time window +14 days) and 6 months (follow-up time window +30 days). Estimated duration of inclusions: 27 months. Total estimated duration of study: 38 months.

Conditions

• Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-03
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2022-02-10
• Last updated: 2024-07-05

Locations

11 sites across 3 countries: France, Germany, Switzerland