Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN

Shanghai AngioCare Medical90 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Transfemoral Renal DenervationPROCEDURE

Radiofrequency renal denervation using the Iberis Renal Denervation System treated via femoral artery access

Transradial Renal DenervationPROCEDURE

Radiofrequency renal denervation using the Iberis Renal Denervation System treated via radial artery access

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (11)

Hôpital Saint André

Bordeaux, France

RECRUITING

Hôpital Jacques Cartier

Massy, France

RECRUITING

Outcomes

Primary Outcomes

Change in office systolic blood pressure at 3 months.

Mean of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)

Time frame: 3 months

Secondary Outcomes

Procedural success

Number of participants with successful completion of the renal denervation procedure via the intended approach

Time frame: Procedure

Number of ablations per patient

Number of ablations performed during the procedure for each participants

Time frame: Procedure

Procedural duration

Lenght of the procedure

Time frame: Procedure

X-Ray exposure

Level of X-Ray exposure

Time frame: Procedure

Volume of contrast media

Volume of contrast media use during the procedure

Time frame: 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

Time frame: Discharge or at least 24hours after procedure)

Office systolic blood pressure

Mean of 3 readings at 1-minute intervals after a 5-minute resting period in the examination room (mmHg)

Central Contacts

Bradley S Hubbard, DVM

CONTACT

713-818-3188 bshdvm@gmail.com

Data from ClinicalTrials.gov

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