Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN (RADIUS-HTN)

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, 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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Procedure: Transradial Renal Denervation; Procedure: Transfemoral Renal Denervation

Detailed Description

Non-inferiority, prospective, multi-center, international, post-market, randomized (1:1) clinical trial.

90 patients with uncontrolled hypertension treated with 2 to 5 antihypertensive drugs including one angiotensin receptor blocker (ARB) or angiotensin-converting enzyme Inhibitor (ACE-I) in combination with one diuretic or calcium channel blocker will be randomized in a 1:1 ratio to the radial access renal denervation group (intervention) or the femoral access renal denervation group (control).

Around 12 sites in 3 European countries (France, Germany and Switzerland) are planned to enroll 90 patients.

For patients with a contraindication for the TransFemoral Access (major femoral disease, bilateral femoral vascular prosthesis, extreme obesity), a register is also carried out in parallel with the study. The inclusion and exclusion criteria will be the same except the fact that patients have to be eligible for TransFemoral access, endpoints and data collected will be the same.

All patients will be followed per standard of care practice and follow-up visits are scheduled at 3 months (follow-up time window +14 days) and 6 months (follow-up time window +30 days).

Estimated duration of inclusions: 27 months. Total estimated duration of study: 38 months.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bradley S Hubbard, DVM; Phone Number: 713-818-3188; Email: bshdvm@gmail.com

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • Hôpital Saint André
    • Contact: Antoine Cremer, MD
  • Massy, France, 91300
    • Recruiting
    • Hopital Jacques Cartier
    • Contact: Hakim Benamer, MD
  • Pau, France, 64000
    • Recruiting
    • Centre Hospitalier de Pau
    • Contact: Nicolas Delarche, MD
  • Toulouse, France, 31300
    • Recruiting
    • Clinique Pasteur
    • Contact: Benjamin Honton, MD
• Germany
  • Dresden, Germany, 01099
    • Recruiting
    • Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR
    • Contact: Gregor Simonis, MD
  • Hamburg, Germany, 20099
    • Recruiting
    • Asklepios Klinik Altona
    • Contact: Martin Bergmann, MD
  • Homburg, Germany, 66421
    • Recruiting
    • Saarland University Hospital
    • Contact: Saarraaken Kulenthiran, MD
  • Stendal, Germany, 39576
    • Recruiting
    • Johanniter-Krankenhaus Genthin-Stendal
    • Contact: Michael Gross, MD
• Switzerland
  • Basel, Switzerland, 4031
    • Not yet recruiting
    • University Hospital Basel
    • Contact: Lucas Lauder, MD
    • Contact: Mahfoud Felix, MD, MA
  • Fribourg, Switzerland, 1708
    • Not yet recruiting
    • University & Hospital Fribourg
    • Contact: Stéphane Cook, MD
  • Lugano, Switzerland, 6900
    • Not yet recruiting
    • Cardiovascolare Istituto Cardiocentro Ticino
    • Contact: Marco Valgimigli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TransRadial access; Patients in this group are thus treated using a TRA approach	Procedure: Transradial Renal Denervation; Radiofrequency renal denervation using the Iberis Renal Denervation System treated via radial artery access; Other Names: TRA RDN
Active Comparator: TransFemoral Access; Patients in this group are thus treated using a TFA approach.	Procedure: Transfemoral Renal Denervation; Radiofrequency renal denervation using the Iberis Renal Denervation System treated via femoral artery access; Other Names: TFA RDN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in office systolic blood pressure at 3 months.	Mean of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Number of participants with successful completion of the renal denervation procedure via the intended approach	Procedure
Number of ablations per patient	Number of ablations performed during the procedure for each participants	Procedure
Procedural duration	Lenght of the procedure	Procedure
X-Ray exposure	Level of X-Ray exposure	Procedure
Volume of contrast media	Volume of contrast media use during the procedure	Procedure
Home heart rate	3 measurements in the morning and evening	7 days prior to baseline/randomization and before every follow-up
Renal function	change of estimated-Glomerular Filtration Rate (eGFR)	3 months and 6 months
Changes in medication (DDD Defined Daily Doses)		3 and 6 months
Percentage of Vascular Access Site Complication (VASC)		Discharge (up to 48 hours), 3 and 6 months
Patient satisfaction	Assessed by the Medical Outcomes Study Short Form 36-item health status questionnaire (acute SF-36) and a series of procedure-specific questions	Discharge (up to 48 hours) and 3 months
Major vascular events	major hematoma, pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, arterial thrombosis, dissection and perforation, distal embolization, femoral nerve injury, local infection and arterial avulsion	Discharge or at least 24hours after procedure)
Office systolic blood pressure	Mean of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)	6 months
Office diastolic blood pressure	Mean of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)	3 months and 6 months
Mean 24-hour ambulatory systolic and diastolic blood pressure		3 months and 6 months
Daytime (7:00 am to 10:00 pm) and nighttime (10:00 pm to 7:00 am) ambulatory systolic and diastolic blood pressure	Mean (mmHg)	3 months and 6 months
Percentage of patients at target blood pressure		3 months and 6 months
Office heart rate	beats per minute	3 months and 6 months
Ambulatory heart rate	beat per minute	3 months and 6 months
Home blood pressure	3 measurements in the morning and evening for 7 days	7 days prior to baseline/randomization and before every follow-up
Renal artery safety	absence of renal re-intervention, renal artery stenosis or dissection.	6 months
Length of in-hospital stay		Discharge (up to 48 hours)
Percentage of stroke / TIA	Percentage of stroke and/or transient ischemic attack	Discharge (up to 48 hours), 3 and 6 months
Percentage of Bleeding	Percentage of bleeding (BARC 3 to 5)	Discharge (up to 48 hours), 3 and 6 months
Time in target range		3 and 6 months

Collaborators and Investigators

• Sponsor: Shanghai AngioCare Medical
• Investigators: Principal Investigator: Felix Mahfoud, MD, MA, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Uncontrolled Hypertension; Renal Denervation; TransRadial
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: BIO-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No