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New treatment option for Hypertension
Official title Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN
ClinicalTrials.gov ID: NCT05234788
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patient ≥18 and ≤75 years old
- Persistent uncontrolled hypertension defined as the mean of three consecutive measurements of systolic office blood pressure \>150 mmHg and diastolic...
- Renal artery diameter ≥3 mm and ≤8 mm (to be assessed during the procedure)
- Patient can be treated according to the instructions for use (IFU)
- Patient eligible for TransFemoral Access and TransRadial Access
You likely can't join if
- Estimated glomerular filtration rate (eGFR) \<45 mL/min/m² (MDRD formula)
- Prior renal transplant
- Presence of accessory artery (polar artery) supplying more than 20% of renal parenchyma that cannot be treated (renal artery diameter \<3 mm) with...
- 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
See the full eligibility criteria
- Patient ≥18 and ≤75 years old
- 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...
- Renal artery diameter ≥3 mm and ≤8 mm (to be assessed during the procedure)
- Patient can be treated according to the instructions for use (IFU)
- Patient eligible for TransFemoral Access and TransRadial Access
- Patient, who understands the trial requirements and the treatment procedures and provides written informed consent
- Estimated glomerular filtration rate (eGFR) \<45 mL/min/m² (MDRD formula)
- Prior renal transplant
- 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
- 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
- people under judicial protection, guardianship or curatorship or people deprived of their liberty by judicial or administrative decision
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Massy, France
- Pau, France
- Toulouse, France
- Dresden, Germany
- Hamburg, Germany
- Homburg, Germany
- Stendal, Germany
- Basel, Switzerland
- Fribourg, Switzerland
- Lugano, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Massy, France; Pau, France; Toulouse, France; Dresden, Germany; Hamburg, Germany and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.