TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)

ReCor Medical

Status: Completed

Conditions: Resistant Hypertension

Treatments: Device: PARADISE percutaneous renal denervation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01789918

CLIN-0030-HT

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

96 participants in 1 patient group

Percutaneous renal denervation

Experimental group

Description:

PARADISE percutaneous renal denervation

Treatment:

Device: PARADISE percutaneous renal denervation