REnAL denervatIon by ultraSound Transcatheter Emission (REALISE)

July 5, 2018 updated by: ReCor Medical, Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 1048
        • Université de Toulouse et CHU
    • Île-de-France
      • Paris, Île-de-France, France, 75013
        • Hôpital Pitié-Salpétrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Percutaneous renal denervation
Device: PARADISE percutaneous renal denervation
Intravascular ultrasound emission
Other Names:
  • ReCor Medical PARADISE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of successful interventions
Time Frame: Up to 24 hours

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
Up to 24 hours
Percentage of patients with device- or procedure-related adverse events
Time Frame: 12 months

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.)
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in ambulatory blood pressure
Time Frame: 12 months
12 months
Change from baseline in anti-hypertensive medication intake
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ReCor Medical, Inc.

Investigators

  • Principal Investigator: Gilles Montalescot, Professor, Hôpital Pitié-Salpétrière

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

February 6, 2012

First Posted (Estimate)

February 8, 2012

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 5, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-0020-HT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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