REnAL denervatIon by ultraSound Transcatheter Emission

ReCor Medical, Inc.20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Resistant Hypertension

Interventions

PARADISE percutaneous renal denervationDEVICE

Intravascular ultrasound emission

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Université de Toulouse et CHU

Toulouse, France

Hôpital Pitié-Salpêtrière

Paris, Île-de-France Region, France

Outcomes

Primary Outcomes

Percentage of successful interventions

A successful intervention is defined by the ability to successfully: 1. Introduce the PRDS catheter 2. Position the PRDS catheter 3. Deliver ultrasound energy 4. Retrieve the PRDS catheter

Time frame: Up to 24 hours

Percentage of patients with device- or procedure-related adverse events

Anticipated adverse events include: * Puncture site-related events * Renal artery stenosis, aneurysm, dissection, or perforation * Renal infarction, acute kidney injury, or renal failure * Arterial and venous thromboembolic events (including myocardial infarction, stroke, aortic or peripheral artery disease, etc.)

Time frame: 12 months

Secondary Outcomes

Change from baseline in ambulatory blood pressure

Time frame: 12 months

Change from baseline in anti-hypertensive medication intake

Time frame: 12 months

Data from ClinicalTrials.gov

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