Phase
Condition
Williams Syndrome
Vascular Diseases
Stress
Treatment
Transfemoral Renal Denervation
Transradial Renal Denervation
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient ≥18 and ≤75 years old
Persistent uncontrolled hypertension defined as the mean of three consecutivemeasurements of systolic office blood pressure >150 mmHg and diastolic office bloodpressure >80 mmHg as well as ambulatory daytime systolic blood pressure ≥140 mmHgdespite prescription of 2 to 5 anti-hypertensive drugs including anangiotensin-receptor blocker or an angiotensin-converting enzyme inhibitor incombination 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 andprovides written informed consent
Exclusion
Exclusion Criteria:
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 renalparenchyma that cannot be treated (renal artery diameter <3 mm) with renaldenervation
Patient lacking capacity (i.e. patient suffering from dementia and others) toprovide informed consent
Patient currently participating in another investigational drug or device study
Pregnant or breastfeeding women or those intending to become pregnant before the endof the follow-up
Subjects under judicial protection, guardianship or curatorship or subjects deprivedof their liberty by judicial or administrative decision
Study Design
Study Description
Connect with a study center
Hôpital Saint André
Bordeaux, 33000
FranceActive - Recruiting
Hôpital Jacques Cartier
Massy, 91300
FranceActive - Recruiting
Centre Hospitalier de Pau
Pau, 64000
FranceActive - Recruiting
Clinique Pasteur
Toulouse, 31300
FranceActive - Recruiting
Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR
Dresden, 01099
GermanyActive - Recruiting
Asklepios Klinik Altona
Hamburg, 20099
GermanyActive - Recruiting
Saarland University Hospital
Homburg, 66421
GermanyActive - Recruiting
Johanniter-Krankenhaus Genthin-Stendal
Stendal, 39576
GermanyActive - Recruiting
University Hospital Basel
Basel, 4031
SwitzerlandSite Not Available
University & Hospital Fribourg
Fribourg, 1708
SwitzerlandSite Not Available
Cardiovascolare Istituto Cardiocentro Ticino
Lugano, 6900
SwitzerlandSite Not Available
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