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Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN
Sponsor: Shanghai AngioCare Medical
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.
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-08-03
Completion Date
2025-12-01
Last Updated
2024-07-05
Healthy Volunteers
No
Conditions
Interventions
Transfemoral Renal Denervation
Radiofrequency renal denervation using the Iberis Renal Denervation System treated via femoral artery access
Transradial Renal Denervation
Radiofrequency renal denervation using the Iberis Renal Denervation System treated via radial artery access
Locations (11)
Hôpital Saint André
Bordeaux, France
Hôpital Jacques Cartier
Massy, France
Centre Hospitalier de Pau
Pau, France
Clinique Pasteur
Toulouse, France
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR
Dresden, Germany
Asklepios Klinik Altona
Hamburg, Germany
Saarland University Hospital
Homburg, Germany
Johanniter-Krankenhaus Genthin-Stendal
Stendal, Germany
University Hospital Basel
Basel, Switzerland
University & Hospital Fribourg
Fribourg, Switzerland
Cardiovascolare Istituto Cardiocentro Ticino
Lugano, Switzerland