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HypertensionRADIUS-HTNNCT05234788

Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN

A study testing Transfemoral Renal Denervation and Transradial Renal Denervation in people with Hypertension, run by Shanghai AngioCare Medical at 11 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertension
What is being tested?
Transfemoral Renal Denervation and Transradial Renal Denervation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
11 sitesin 3 countries
Study dates
3 Aug 2023to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 3 countries.

Bradley S Hubbard, DVM contact

713-818-3188

bshdvm@gmail.com

11 sites in 3 countries

France4 sites, 4 recruiting

  • Hôpital Saint André

    Bordeaux, 33000

    Antoine Cremer, MD

    Recruiting

  • Hôpital Jacques Cartier

    Massy, 91300

    Hakim Benamer, MD

    Recruiting

  • Centre Hospitalier de Pau

    Pau, 64000

    Nicolas Delarche, MD

    Recruiting

  • Clinique Pasteur

    Toulouse, 31300

    Benjamin Honton, MD

    Recruiting

Other trials in France

Germany4 sites, 4 recruiting

  • Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR

    Dresden, 01099

    Gregor Simonis, MD

    Recruiting

  • Asklepios Klinik Altona

    Hamburg, 20099

    Martin Bergmann, MD

    Recruiting

  • Saarland University Hospital

    Homburg, 66421

    Saarraaken Kulenthiran, MD

    Recruiting

  • Johanniter-Krankenhaus Genthin-Stendal

    Stendal, 39576

    Michael Gross, MD

    Recruiting

Other trials in Germany

Switzerland3 sites, 3 recruiting

  • University Hospital Basel

    Basel, 4031

    Lucas Lauder, MD

    Mahfoud Felix, MD, MA

    Not yet recruiting

  • University & Hospital Fribourg

    Fribourg, 1708

    Stéphane Cook, MD

    Not yet recruiting

  • Cardiovascolare Istituto Cardiocentro Ticino

    Lugano, 6900

    Marco Valgimigli, MD

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: 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.

Read the 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
Being tested
Transfemoral Renal Denervation, Transradial Renal Denervation
Keywords
Renal Denervation, TransRadial, Uncontrolled Hypertension
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transfemoral Renal DenervationProcedure or surgery

    Also called TFA RDN

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

  • Transradial Renal DenervationProcedure or surgery

    Also called TRA RDN

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

Study groups in NCT05234788
Study groupRoleWhat they receive
TransRadial accessExperimentalPatients in this group are thus treated using a TRA approach
Receives: Procedure: Transradial Renal Denervation
TransFemoral AccessActive comparatorPatients in this group are thus treated using a TFA approach.
Receives: Procedure: Transfemoral Renal Denervation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 months

Secondary outcomes (24)

  1. Procedural success

    Number of participants with successful completion of the renal denervation procedure via the intended approach

    Measured: Procedure

  2. Number of ablations per patient

    Number of ablations performed during the procedure for each participants

    Measured: Procedure

  3. Procedural duration

    Lenght of the procedure

    Measured: Procedure

  4. X-Ray exposure

    Level of X-Ray exposure

    Measured: Procedure

  5. Volume of contrast media

    Volume of contrast media use during the procedure

    Measured: Procedure

  6. 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

    Measured: Discharge or at least 24hours after procedure)

  7. Office systolic blood pressure

    Mean of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)

    Measured: 6 months

  8. Office diastolic blood pressure

    Mean of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)

    Measured: 3 months and 6 months

  9. Mean 24-hour ambulatory systolic and diastolic blood pressure

    Measured: 3 months and 6 months

  10. 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)

    Measured: 3 months and 6 months

  11. Percentage of patients at target blood pressure

    Measured: 3 months and 6 months

  12. Office heart rate

    beats per minute

    Measured: 3 months and 6 months

  13. Ambulatory heart rate

    beat per minute

    Measured: 3 months and 6 months

  14. Home blood pressure

    3 measurements in the morning and evening for 7 days

    Measured: 7 days prior to baseline/randomization and before every follow-up

  15. Home heart rate

    3 measurements in the morning and evening

    Measured: 7 days prior to baseline/randomization and before every follow-up

  16. Renal function

    change of estimated-Glomerular Filtration Rate (eGFR)

    Measured: 3 months and 6 months

  17. Renal artery safety

    absence of renal re-intervention, renal artery stenosis or dissection.

    Measured: 6 months

  18. Changes in medication (DDD Defined Daily Doses)

    Measured: 3 and 6 months

  19. Length of in-hospital stay

    Measured: Discharge (up to 48 hours)

  20. Percentage of Vascular Access Site Complication (VASC)

    Measured: Discharge (up to 48 hours), 3 and 6 months

  21. Percentage of stroke / TIA

    Percentage of stroke and/or transient ischemic attack

    Measured: Discharge (up to 48 hours), 3 and 6 months

  22. Percentage of Bleeding

    Percentage of bleeding (BARC 3 to 5)

    Measured: Discharge (up to 48 hours), 3 and 6 months

  23. 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

    Measured: Discharge (up to 48 hours) and 3 months

  24. Time in target range

    Measured: 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2022
  2. Study start3 Aug 2023
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05234788
Sponsor's protocol ID
BIO-01
Acronym
RADIUS-HTN
Status last verified
Jul 2024
First submitted
6 Jan 2022
Last updated
5 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Transfemoral Renal Denervation and Transradial Renal Denervation in people with Hypertension, run by Shanghai AngioCare Medical at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bradley S Hubbard, DVM (713-818-3188, bshdvm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in office systolic blood pressure at 3 months. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05234788.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.

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