Hypertension
Conditions
Keywords
Renal Denervation, TransRadial, Uncontrolled Hypertension
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.
Interventions
PROCEDURETransfemoral Renal Denervation
Radiofrequency renal denervation using the Iberis Renal Denervation System treated via femoral artery access
PROCEDURETransradial Renal Denervation
Radiofrequency renal denervation using the Iberis Renal Denervation System treated via radial artery access
Sponsors
Shanghai AngioCare Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory heart rate | 3 months and 6 months | beat 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 |
| Procedural success | Procedure | Number of participants with successful completion of the renal denervation procedure via the intended approach |
| Number of ablations per patient | Procedure | Number of ablations performed during the procedure for each participants |
| Procedural duration | Procedure | Lenght of the procedure |
| 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 |
| 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) |
| 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) |
| Mean 24-hour ambulatory systolic and diastolic blood pressure | 3 months and 6 months | — |
| Office heart rate | 3 months and 6 months | beats per minute |
| Percentage of patients at target blood pressure | 3 months and 6 months | — |
| Home heart rate | 7 days prior to baseline/randomization and before every follow-up | 3 measurements in the morning and evening |
| Renal function | 3 months and 6 months | change of estimated-Glomerular Filtration Rate (eGFR) |
| 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 | — |
| 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 stroke / TIA | Discharge (up to 48 hours), 3 and 6 months | Percentage of stroke and/or transient ischemic attack |
| Percentage of Bleeding | Discharge (up to 48 hours), 3 and 6 months | Percentage of bleeding (BARC 3 to 5) |
| 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 |
| Time in target range | 3 and 6 months | — |
| 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) |
Countries
France, Germany, Switzerland
Contacts
Primary ContactBradley S Hubbard, DVM
Outcome results
None listed