Status:
RECRUITING
Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN
Lead Sponsor:
Shanghai AngioCare Medical
Conditions:
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 includin...
Eligibility Criteria
Inclusion
- 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 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
- 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
Exclusion
- 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
- Subjects under judicial protection, guardianship or curatorship or subjects deprived of their liberty by judicial or administrative decision
Key Trial Info
Start Date :
August 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05234788
Start Date
August 3 2023
End Date
December 1 2025
Last Update
July 5 2024
Active Locations (11)
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1
Hôpital Saint André
Bordeaux, France, 33000
2
Hôpital Jacques Cartier
Massy, France, 91300
3
Centre Hospitalier de Pau
Pau, France, 64000
4
Clinique Pasteur
Toulouse, France, 31300