Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN

NCT ID: NCT05234788

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-03
• Study Completion Date: 2025-12-01

Brief 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.

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TransRadial access

Patients in this group are thus treated using a TRA approach

Group Type: EXPERIMENTAL

Transradial Renal Denervation

Intervention Type: PROCEDURE

Radiofrequency renal denervation using the Iberis Renal Denervation System treated via radial artery access

TransFemoral Access

Patients in this group are thus treated using a TFA approach.

Group Type: ACTIVE_COMPARATOR

Transfemoral Renal Denervation

Intervention Type: PROCEDURE

Radiofrequency renal denervation using the Iberis Renal Denervation System treated via femoral artery access

Interventions

Transfemoral Renal Denervation

Radiofrequency renal denervation using the Iberis Renal Denervation System treated via femoral artery access

Intervention Type: PROCEDURE

Transradial Renal Denervation

Radiofrequency renal denervation using the Iberis Renal Denervation System treated via radial artery access

Intervention Type: PROCEDURE

Other Intervention Names

TFA RDN; TRA RDN

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai AngioCare Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felix Mahfoud, MD, MA

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

Hôpital Saint André

Bordeaux, , France

Site Status: RECRUITING

Hôpital Jacques Cartier

Massy, , France

Site Status: RECRUITING

Centre Hospitalier de Pau

Pau, , France

Site Status: RECRUITING

Clinique Pasteur

Toulouse, , France

Site Status: RECRUITING

Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR

Dresden, , Germany

Site Status: RECRUITING

Asklepios Klinik Altona

Hamburg, , Germany

Site Status: RECRUITING

Saarland University Hospital

Homburg, , Germany

Site Status: RECRUITING

Johanniter-Krankenhaus Genthin-Stendal

Stendal, , Germany

Site Status: RECRUITING

University Hospital Basel

Basel, , Switzerland

Site Status: NOT_YET_RECRUITING

University & Hospital Fribourg

Fribourg, , Switzerland

Site Status: NOT_YET_RECRUITING

Cardiovascolare Istituto Cardiocentro Ticino

Lugano, , Switzerland

Site Status: NOT_YET_RECRUITING

Countries

France; Germany; Switzerland

Central Contacts

Bradley S Hubbard, DVM

Role: CONTACT

bshdvm@gmail.com

713-818-3188

Facility Contacts

Antoine Cremer, MD

Role: primary

Hakim Benamer, MD

Role: primary

Nicolas Delarche, MD

Role: primary

Benjamin Honton, MD

Role: primary

Gregor Simonis, MD

Role: primary

Martin Bergmann, MD

Role: primary

Saarraaken Kulenthiran, MD

Role: primary

Michael Gross, MD

Role: primary

Lucas Lauder, MD

Role: primary

Mahfoud Felix, MD, MA

Role: backup

Stéphane Cook, MD

Role: primary

Marco Valgimigli, MD

Role: primary

Other Identifiers

BIO-01

Identifier Type: -

Identifier Source: org_study_id