Renal artery denervation for uncontrolled hypertension using radial access

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

This study is testing if a new way to perform renal artery denervation through the wrist can help people with high blood pressure who aren't getting better with their current medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai AngioCare Medical (Industry-sponsored)
• Locations: 11 sites (Bordeaux and 10 other locations)
• Trial ID: NCT05234788 on ClinicalTrials.gov

What this trial studies

This clinical trial is a non-inferiority, prospective, multi-center, international, randomized study comparing the safety and efficacy of renal denervation using the Iberis Renal Denervation System via radial access versus femoral access in patients with uncontrolled hypertension. It aims to enroll 90 patients who are currently on multiple antihypertensive medications but still have high blood pressure. Participants will be followed up at 3 and 6 months post-procedure to assess outcomes. The trial is being conducted across approximately 12 sites in France, Germany, and Switzerland.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with persistent uncontrolled hypertension despite treatment with multiple antihypertensive medications.

Not a fit: Patients with an estimated glomerular filtration rate below 45 mL/min/m² or those who have had a prior renal transplant may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive option for patients with uncontrolled hypertension, potentially improving their blood pressure management.

How similar studies have performed: Other studies have shown promise with renal denervation techniques, but this specific approach using radial access is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patient ≥18 and ≤75 years old
2. 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
3. Renal artery diameter ≥3 mm and ≤8 mm (to be assessed during the procedure)
4. Patient can be treated according to the instructions for use (IFU)
5. Patient eligible for TransFemoral Access and TransRadial Access
6. Patient, who understands the trial requirements and the treatment procedures and provides written informed consent

Exclusion Criteria:

1. Estimated glomerular filtration rate (eGFR) \<45 mL/min/m² (MDRD formula)
2. Prior renal transplant
3. 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
4. Patient lacking capacity (i.e. patient suffering from dementia and others) to provide informed consent
5. Patient currently participating in another investigational drug or device study
6. Pregnant or breastfeeding women or those intending to become pregnant before the end of the follow-up
7. Subjects under judicial protection, guardianship or curatorship or subjects deprived of their liberty by judicial or administrative decision

Where this trial is running

Bordeaux and 10 other locations

• Hôpital Saint André — Bordeaux, France (Recruiting)
• Hôpital Jacques Cartier — Massy, France (Recruiting)
• Centre Hospitalier de Pau — Pau, France (Recruiting)
• Clinique Pasteur — Toulouse, France (Recruiting)
• Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR — Dresden, Germany (Recruiting)
• Asklepios Klinik Altona — Hamburg, Germany (Recruiting)
• Saarland University Hospital — Homburg, Germany (Recruiting)
• Johanniter-Krankenhaus Genthin-Stendal — Stendal, Germany (Recruiting)
• University Hospital Basel — Basel, Switzerland (Not_yet_recruiting)
• University & Hospital Fribourg — Fribourg, Switzerland (Not_yet_recruiting)
• Cardiovascolare Istituto Cardiocentro Ticino — Lugano, Switzerland (Not_yet_recruiting)

Study contacts

• Principal investigator: Felix Mahfoud, MD, MA — University Hospital, Basel, Switzerland
• Study coordinator: Bradley S Hubbard, DVM

Conditions Hypertension; Renal Denervation; TransRadial; Uncontrolled Hypertension