Actively Recruiting
Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN
Led by Shanghai AngioCare Medical · Updated on 2024-07-05
90
Participants Needed
11
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 to 75 years old
- Persistent uncontrolled hypertension with systolic office blood pressure >150 mmHg and diastolic office blood pressure >80 mmHg and ambulatory daytime systolic blood pressure ≥140 mmHg
- Treated with 2 to 5 antihypertensive drugs including an angiotensin receptor blocker or angiotensin-converting enzyme inhibitor plus a diuretic or calcium channel blocker
- Renal artery diameter between 3 mm and 8 mm
- Eligible for both TransFemoral and TransRadial Access
- Able to understand trial requirements and provide written informed consent
You will not qualify if you...
- Estimated glomerular filtration rate (eGFR) less than 45 mL/min/m²
- Prior renal transplant
- Presence of accessory artery supplying more than 20% of renal parenchyma that cannot be treated
- Unable to provide informed consent due to lack of capacity
- Currently participating in another investigational drug or device study
- Pregnant, breastfeeding, or intending to become pregnant before study end
- Under judicial protection, guardianship, or deprived of liberty by judicial or administrative decision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Hôpital Saint André
Bordeaux, France, 33000
Actively Recruiting
2
Hôpital Jacques Cartier
Massy, France, 91300
Actively Recruiting
3
Centre Hospitalier de Pau
Pau, France, 64000
Actively Recruiting
4
Clinique Pasteur
Toulouse, France, 31300
Actively Recruiting
5
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR
Dresden, Germany, 01099
Actively Recruiting
6
Asklepios Klinik Altona
Hamburg, Germany, 20099
Actively Recruiting
7
Saarland University Hospital
Homburg, Germany, 66421
Actively Recruiting
8
Johanniter-Krankenhaus Genthin-Stendal
Stendal, Germany, 39576
Actively Recruiting
9
University Hospital Basel
Basel, Switzerland, 4031
Not Yet Recruiting
10
University & Hospital Fribourg
Fribourg, Switzerland, 1708
Not Yet Recruiting
11
Cardiovascolare Istituto Cardiocentro Ticino
Lugano, Switzerland, 6900
Not Yet Recruiting
Research Team
B
Bradley S Hubbard, DVM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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