Clinical trial NCT05234788: Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Renal Denervation
TransRadial
Uncontrolled Hypertension
Lead sponsor: Shanghai AngioCare Medical
Sponsor class: INDUSTRY
First posted: 2022-02-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in office systolic blood pressure at 3 months.
timeFrame: 3 months
Secondary outcomes:
measure: Procedural success
timeFrame: Procedure
measure: Number of ablations per patient
timeFrame: Procedure
measure: Procedural duration
timeFrame: Procedure
measure: X-Ray exposure
timeFrame: Procedure
measure: Volume of contrast media
timeFrame: Procedure
measure: Major vascular events
timeFrame: Discharge or at least 24hours after procedure)
measure: Office systolic blood pressure
timeFrame: 6 months
measure: Office diastolic blood pressure
timeFrame: 3 months and 6 months
measure: Mean 24-hour ambulatory systolic and diastolic blood pressure
timeFrame: 3 months and 6 months
measure: Daytime (7:00 am to 10:00 pm) and nighttime (10:00 pm to 7:00 am) ambulatory systolic and diastolic blood pressure
timeFrame: 3 months and 6 months
measure: Percentage of patients at target blood pressure
timeFrame: 3 months and 6 months
measure: Office heart rate
timeFrame: 3 months and 6 months
measure: Ambulatory heart rate
timeFrame: 3 months and 6 months
measure: Home blood pressure
timeFrame: 7 days prior to baseline/randomization and before every follow-up
measure: Home heart rate
timeFrame: 7 days prior to baseline/randomization and before every follow-up
measure: Renal function
timeFrame: 3 months and 6 months
measure: Renal artery safety
timeFrame: 6 months
measure: Changes in medication (DDD Defined Daily Doses)
timeFrame: 3 and 6 months
measure: Length of in-hospital stay
timeFrame: Discharge (up to 48 hours)
measure: Percentage of Vascular Access Site Complication (VASC)
timeFrame: Discharge (up to 48 hours), 3 and 6 months
measure: Percentage of stroke / TIA
timeFrame: Discharge (up to 48 hours), 3 and 6 months
measure: Percentage of Bleeding
timeFrame: Discharge (up to 48 hours), 3 and 6 months
measure: Patient satisfaction
timeFrame: Discharge (up to 48 hours) and 3 months
measure: Time in target range
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Saint André
city: Massy
country: France
facility: Hôpital Jacques Cartier
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Toulouse
country: France
facility: Clinique Pasteur
city: Dresden
country: Germany
facility: Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Homburg
country: Germany
facility: Saarland University Hospital
city: Stendal
country: Germany
facility: Johanniter-Krankenhaus Genthin-Stendal
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Fribourg
country: Switzerland
facility: University & Hospital Fribourg
city: Lugano
country: Switzerland
facility: Cardiovascolare Istituto Cardiocentro Ticino
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Felix Mahfoud, MD, MA
role: PRINCIPAL_INVESTIGATOR
References: