Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN

Last updated: July 3, 2024
Sponsor: Shanghai AngioCare Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Vascular Diseases

Stress

Treatment

Transfemoral Renal Denervation

Transradial Renal Denervation

Clinical Study ID

NCT05234788
BIO-01
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient ≥18 and ≤75 years old

  2. Persistent uncontrolled hypertension defined as the mean of three consecutivemeasurements of systolic office blood pressure >150 mmHg and diastolic office bloodpressure >80 mmHg as well as ambulatory daytime systolic blood pressure ≥140 mmHgdespite prescription of 2 to 5 anti-hypertensive drugs including anangiotensin-receptor blocker or an angiotensin-converting enzyme inhibitor incombination 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 andprovides written informed consent

Exclusion

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 renalparenchyma that cannot be treated (renal artery diameter <3 mm) with renaldenervation

  4. Patient lacking capacity (i.e. patient suffering from dementia and others) toprovide 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 endof the follow-up

  7. Subjects under judicial protection, guardianship or curatorship or subjects deprivedof their liberty by judicial or administrative decision

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Transfemoral Renal Denervation
Phase:
Study Start date:
August 03, 2023
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • Hôpital Saint André

    Bordeaux, 33000
    France

    Active - Recruiting

  • Hôpital Jacques Cartier

    Massy, 91300
    France

    Active - Recruiting

  • Centre Hospitalier de Pau

    Pau, 64000
    France

    Active - Recruiting

  • Clinique Pasteur

    Toulouse, 31300
    France

    Active - Recruiting

  • Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR

    Dresden, 01099
    Germany

    Active - Recruiting

  • Asklepios Klinik Altona

    Hamburg, 20099
    Germany

    Active - Recruiting

  • Saarland University Hospital

    Homburg, 66421
    Germany

    Active - Recruiting

  • Johanniter-Krankenhaus Genthin-Stendal

    Stendal, 39576
    Germany

    Active - Recruiting

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Site Not Available

  • University & Hospital Fribourg

    Fribourg, 1708
    Switzerland

    Site Not Available

  • Cardiovascolare Istituto Cardiocentro Ticino

    Lugano, 6900
    Switzerland

    Site Not Available

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