Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN

Study Overview
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Brief Summary
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Non-inferiority, prospective, multi-center, post-market, randomized 1:1 study 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
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Non-inferiority, prospective, multi-center, post-market, randomized 1:1 study. 90 patients with uncontrolled hypertension treated with 2 to 5 anti-hypertensive drugs including one Angiotensin Receptor Blocker (ARB) associated to one diuretic or Calcium Channel blocker. 12 sites will be selected in 3 countries (France, Germany and Monaco) to enroll 90 patients. A parallel registry on radial approach only (patients who cannot be treated by femoral ) will have the same follow up. Each patients will have two follow-ups: at 3 months (90+14) at 6 months (180+30) The expected duration of the inclusion is 15 months. The estimated duration of the Study is 26 months.

Official Title
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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

Conditions
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Uncontrolled Hypertension, Renal Denervation, TransRadial

Intervention / Treatment
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* Procedure: Renal Denervation surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥18 and ≤75 years old Persistent uncontrolled hypertension defined as Mean of three measurements systolic office >150 mmHg, mean diastolic >80 mmHg, corresponding ambulatory blood pressure mean ≥140 mmHg (24 hours daytime mean) despite prescription of 2 to 5 anti-hypertensive drugs including one ARB associated to one diuretic or Calcium Channel blocker Renal artery diameter ≥3 mm (to be assessed during the procedure) Patient eligible for TransFemoral Access and TransRadial Access Patient who understands the trial requirements and the treatment procedures and provides written informed consent Exclusion Criteria: eGFR >45 mL/min/m² Prior renal artery intervention Prior renal transplant Presence of accessory artery (polar artery) supplying more than 20% of renal surface that cannot be treated (diameter <3 mm) during the procedure 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TransRadial access<br>Patients in this group are thus treated using a TRA approach | Procedure: Renal Denervation surgery<br>* Renal Denervation surgery using TransRadial Access<br>* Other names: RDN;|
| Active Comparator: TransFemoral Access<br>Patients in this group are thus treated using a TFA approach. | Procedure: Renal Denervation surgery<br>* Renal Denervation surgery using TransRadial Access<br>* Other names: RDN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of systolic office systolic blood pressure (OBP) at 3 months. | A routine OBP measurement is defined as the average of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Number of participants with successful completion of the renal denervation procedure via the intended approach | Procedure | 
| Number of ablations per patient | Number of ablations performed during the procedure for each participants | Procedure | 
| Procedural duration | Lenght of the procedure | Procedure | 
| X-Ray exposure | Level of X-Ray exposure | Procedure | 
| Volume of contrast media | Volume of contrast media use during the procedure | Procedure | 
| 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 | Hospitalisation (at least 24hours after procedure) | 
| Office systolic blood pressure | 3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg) | 6 months | 
| Office diastolic blood pressure | 3 readings at 1-minute intervals after a 5-minute resting period in the examination room | 3 months and 6 months | 
| Ambulatory (24 h) blood pressure | Mean (mmHg) | 3 months and 6 months | 
| Daytime (7:00 am to 10:00 pm) and nighttime (10:00 pm to 7:00 am) BP | Mean (mmHg) | 3 months and 6 months | 
| Percentage of patients at target BP | Percentage of patient with mean systolic OBP <150 mmHg and min diastolic OBP < 80 mmHg | 3 months and 6 months | 
| Office heart rate | BPM | 3 months and 6 months | 
| Ambulatory heart rate | BPM | 3 months and 6 months | 
| Home BP | 3 measurements in the morning and evening | 7 days prior to baseline/randomization and before every follow-up | 
| Home heart rate | 3 measurements in the morning and evening | 7 days prior to baseline/randomization and before every follow-up | 
| Renal function | change of estimated-Glomerular Filtration Rate (eGFR) | 3 months and 6 months | 
| Renal artery safety | absence of renal re intervention, renal artery stenosis or dissection. This will be assesed during the follow-up by asking patients if he had some adverse events after the procedure. If yes, it will be asked to the patient to detailed and some documents about the event will be collected and adjudicated by a Clinical Event Committee | 6 months | 
| Changes in medication (DDD Defined Daily Doses) |  | 3 and 6 months | 
| Length of in hospital stay |  | Discharge (up to 48 hours) | 
| Percentage of Vascular Access Site Complication (VASC) |  | Discharge (up to 48 hours), 3 and 6 months | 
| Percentage of Cerebrovascular events |  | Discharge (up to 48 hours), 3 and 6 months | 
| Percentage of Bleeding |  | Discharge (up to 48 hours), 3 and 6 months | 
| 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 | Discharge (up to 48 hours) and 3 months |