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

Shanghai AngioCare Medical

Status: Enrolling

Conditions: Hypertension

Treatments: Procedure: Transradial Renal Denervation; Procedure: Transfemoral Renal Denervation

Study type: Interventional

Funder types: Industry

Identifiers

NCT05234788

BIO-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

TransRadial access

Experimental group

Description:

Patients in this group are thus treated using a TRA approach

Treatment:

Procedure: Transradial Renal Denervation

TransFemoral Access

Active Comparator group

Description:

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

Treatment:

Procedure: Transfemoral Renal Denervation