TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation

The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to include up to one hundred (100) eligible patients as defined within the clinical investigational plan, with a twelve month follow-up period. The ACHIEVE study was originally designed in accordance with the 2007 ESH ESC guidelines for resistant hypertension.

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
• Untreated allergy to contrast media
• Currently participating in the study of an investigational drug or device
• Moderate to severe renal insufficiency