REnAL denervatIon by ultraSound Transcatheter Emission (REALISE)

ReCor Medical

Status: Completed

Conditions: Resistant Hypertension

Treatments: Device: PARADISE percutaneous renal denervation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529372

CLIN-0020-HT

Details and patient eligibility

About

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.

Enrollment: 20 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
• Allergy to contrast media
• Currently participating in the study of an investigational drug or device
• Hemodynamics abnormality
• Moderate to severe renal insufficiency

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Percutaneous renal denervation

Experimental group

Treatment:

Device: PARADISE percutaneous renal denervation