Skip to main content
OpenTrials
Completed

NCT Number: NCT01529372

REnAL denervatIon by ultraSound Transcatheter Emission

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Resistant Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pitié-Salpêtrière, Paris, Île-de-France Region, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PARADISE percutaneous renal denervation

Device

Intravascular ultrasound emission

Other names: ReCor Medical PARADISE

Primary outcomes

  1. Percentage of successful interventions

    Time frame: Up to 24 hours

    A successful intervention is defined by the ability to successfully:

    • Introduce the PRDS catheter
    • Position the PRDS catheter
    • Deliver ultrasound energy
    • Retrieve the PRDS catheter

  2. 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.)

Secondary outcomes

  1. Change from baseline in ambulatory blood pressure

    Time frame: 12 months

  2. Change from baseline in anti-hypertensive medication intake

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

ReCor Medical, Inc.

Industry

Registry information

Acronym: REALISE

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 8, 2012
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.