NCT05234788

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable hypertension

Geographic Reach
3 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 3, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

January 6, 2022

Last Update Submit

July 3, 2024

Conditions

Hypertension

Keywords

Renal DenervationTransRadialUncontrolled Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (24)

  • Procedural success

    Procedure

  • Number of ablations per patient

    Procedure

  • Procedural duration

    Procedure

  • X-Ray exposure

    Procedure

  • Volume of contrast media

    Procedure

  • +19 more secondary outcomes

Study Arms (2)

TransRadial access

EXPERIMENTAL

Patients in this group are thus treated using a TRA approach

Procedure: Transradial Renal Denervation

TransFemoral Access

ACTIVE COMPARATOR

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

Procedure: Transfemoral Renal Denervation

Interventions

Transfemoral Renal DenervationPROCEDURE

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

Also known as: TFA RDN
TransFemoral Access
Transradial Renal DenervationPROCEDURE

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

Also known as: TRA RDN
TransRadial access

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hôpital Saint André

Bordeaux, 33000, France

RECRUITING

Hôpital Jacques Cartier

Massy, 91300, France

RECRUITING

Centre Hospitalier de Pau

Pau, 64000, France

RECRUITING

Clinique Pasteur

Toulouse, 31300, France

RECRUITING

Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR

Dresden, 01099, Germany

RECRUITING

Asklepios Klinik Altona

Hamburg, 20099, Germany

RECRUITING

Saarland University Hospital

Homburg, 66421, Germany

RECRUITING

Johanniter-Krankenhaus Genthin-Stendal

Stendal, 39576, Germany

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

NOT YET RECRUITING

University & Hospital Fribourg

Fribourg, 1708, Switzerland

NOT YET RECRUITING

Cardiovascolare Istituto Cardiocentro Ticino

Lugano, 6900, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Felix Mahfoud, MD, MA

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bradley S Hubbard, DVM

CONTACT

713-818-3188bshdvm@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2022

First Posted

February 10, 2022

Study Start

August 3, 2023

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

July 5, 2024

Record last verified: 2024-07

Locations

DE(4)FR(4)CH(3)