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
Shanghai AngioCare Medical
90 participants
Aug 3, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Patient ≥18 and ≤75 years old
- Persistent uncontrolled hypertension defined as the mean of three consecutive measurements of systolic office blood pressure \>150 mmHg and diastolic office blood pressure \>80 mmHg as well as ambulatory daytime systolic blood pressure ≥140 mmHg despite prescription of 2 to 5 anti-hypertensive drugs including an angiotensin-receptor blocker or an angiotensin-converting enzyme inhibitor in combination with a diuretic or calcium channel blocker
- Renal artery diameter ≥3 mm and ≤8 mm (to be assessed during the procedure)
- Patient can be treated according to the instructions for use (IFU)
- Patient eligible for TransFemoral Access and TransRadial Access
- Patient, who understands the trial requirements and the treatment procedures and provides written informed consent
Exclusion Criteria7
- Estimated glomerular filtration rate (eGFR) \<45 mL/min/m² (MDRD formula)
- Prior renal transplant
- Presence of accessory artery (polar artery) supplying more than 20% of renal parenchyma that cannot be treated (renal artery diameter \<3 mm) with renal denervation
- Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent
- Patient currently participating in another investigational drug or device study
- Pregnant or breastfeeding women or those intending to become pregnant before the end of the follow-up
- Subjects under judicial protection, guardianship or curatorship or subjects deprived of their liberty by judicial or administrative decision
Interventions
Radiofrequency renal denervation using the Iberis Renal Denervation System treated via femoral artery access
Radiofrequency renal denervation using the Iberis Renal Denervation System treated via radial artery access
Locations(11)
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NCT05234788