Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Procedure: Transfemoral Renal Denervation; Procedure: Transradial Renal Denervation

• Registration Number: NCT05234788
• Lead Sponsor: Shanghai AngioCare Medical

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.

Study Timeline

• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-10
• Study Start: 2023-08-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TransFemoral Access	Transfemoral Renal Denervation	Patients in this group are thus treated using a TFA approach.
TransRadial access	Transradial Renal Denervation	Patients in this group are thus treated using a TRA approach

Primary Outcome Measures

Name	Time	Method
Change in office systolic blood pressure at 3 months.	3 months	Mean of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)

Secondary Outcome Measures

Name	Time	Method
Procedural duration	Procedure	Lenght of the procedure
Length of in-hospital stay	Discharge (up to 48 hours)
Procedural success	Procedure	Number of participants with successful completion of the renal denervation procedure via the intended approach
Mean 24-hour ambulatory systolic and diastolic blood pressure	3 months and 6 months
Renal function	3 months and 6 months	change of estimated-Glomerular Filtration Rate (eGFR)
Office systolic blood pressure	6 months	Mean of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)
Daytime (7:00 am to 10:00 pm) and nighttime (10:00 pm to 7:00 am) ambulatory systolic and diastolic blood pressure	3 months and 6 months	Mean (mmHg)
Home heart rate	7 days prior to baseline/randomization and before every follow-up	3 measurements in the morning and evening
Percentage of Bleeding	Discharge (up to 48 hours), 3 and 6 months	Percentage of bleeding (BARC 3 to 5)
Number of ablations per patient	Procedure	Number of ablations performed during the procedure for each participants
X-Ray exposure	Procedure	Level of X-Ray exposure
Volume of contrast media	Procedure	Volume of contrast media use during the procedure
Major vascular events	Discharge or at least 24hours after procedure)	major hematoma, pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, arterial thrombosis, dissection and perforation, distal embolization, femoral nerve injury, local infection and arterial avulsion
Percentage of patients at target blood pressure	3 months and 6 months
Office heart rate	3 months and 6 months	beats per minute
Home blood pressure	7 days prior to baseline/randomization and before every follow-up	3 measurements in the morning and evening for 7 days
Renal artery safety	6 months	absence of renal re-intervention, renal artery stenosis or dissection.
Changes in medication (DDD Defined Daily Doses)	3 and 6 months
Percentage of Vascular Access Site Complication (VASC)	Discharge (up to 48 hours), 3 and 6 months
Patient satisfaction	Discharge (up to 48 hours) and 3 months	Assessed by the Medical Outcomes Study Short Form 36-item health status questionnaire (acute SF-36) and a series of procedure-specific questions
Office diastolic blood pressure	3 months and 6 months	Mean of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)
Percentage of stroke / TIA	Discharge (up to 48 hours), 3 and 6 months	Percentage of stroke and/or transient ischemic attack
Ambulatory heart rate	3 months and 6 months	beat per minute
Time in target range	3 and 6 months

Trial Locations

Locations (11)

Centre Hospitalier de Pau; 🇫🇷 Pau, France

Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR; 🇩🇪 Dresden, Germany

Johanniter-Krankenhaus Genthin-Stendal; 🇩🇪 Stendal, Germany

Cardiovascolare Istituto Cardiocentro Ticino; 🇨🇭 Lugano, Switzerland

Saarland University Hospital; 🇩🇪 Homburg, Germany

Hôpital Saint André; 🇫🇷 Bordeaux, France

Clinique Pasteur; 🇫🇷 Toulouse, France

University & Hospital Fribourg; 🇨🇭 Fribourg, Switzerland

Hôpital Jacques Cartier; 🇫🇷 Massy, France

Asklepios Klinik Altona; 🇩🇪 Hamburg, Germany

University Hospital Basel; 🇨🇭 Basel, Switzerland