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

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a radio frequency renal denervation system to treat patients with uncontrolled hypertension. This international, multi-center, randomized clinical trial compares two methods of accessing the renal artery radial access and femoral access. The study focuses on patients who continue to have high blood pressure despite taking multiple antihypertensive medications, including angiotensin receptor blockers or ACE inhibitors combined with diuretics or calcium channel blockers. Participants will be randomly assigned to one of two groups. One group will receive the renal denervation procedure through the radial artery wrist, and the other through the femoral artery groin, both using the Iberis Renal Denervation System. Around 90 patients will be enrolled from about 12 sites across three European countries. The study includes follow-up visits at 3 and 6 months after treatment to monitor outcomes and safety. During the study, patients will have their blood pressure measured in the office, at home, and by ambulatory monitoring. Researchers will also track procedural details, vascular complications, heart rate, renal function, medication changes, and patient satisfaction. Safety assessments include monitoring vascular access site complications, stroke or transient ischemic attacks, and bleeding events. The total duration of the study is approximately 38 months with about 27 months planned for patient enrollment.

Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN