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
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.
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. ;
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