REnAL denervatIon by ultraSound Transcatheter Emission

REnAL denervatIon by ultraSound Transcatheter Emission

The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be conducted on twenty (20) eligible patients with a twelve month follow-up period.

Inclusion Criteria:

• Resistant hypertension, as defined in the 2007 ESH-ESC guidelines
• 18 years of age or older
• Negative pregnancy test for female patients of childbearing potential
• Willing and able to comply with follow-up requirements
• Signed informed consent

Exclusion Criteria:

• Secondary hypertension
• Main renal arteries length < 20 mm
• Main renal arteries diameter < 4 mm
• Renal artery stenosis
• Iliac/femoral artery stenosis precluding insertion of the catheter
• Allergy to contrast media
• Currently participating in the study of an investigational drug or device
• Hemodynamics abnormality
• Moderate to severe renal insufficiency