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REnAL denervatIon by ultraSound Transcatheter Emission (REALISE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by ReCor Medical, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01529372
First Posted: February 8, 2012
Last Update Posted: April 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ReCor Medical, Inc.
  Purpose
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.

Condition Intervention
Resistant Hypertension Device: PARADISE percutaneous renal denervation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: REnAL denervatIon by ultraSound Transcatheter Emission

Further study details as provided by ReCor Medical, Inc.:

Primary Outcome Measures:
  • 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

  • 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 Outcome Measures:
  • Change from baseline in ambulatory blood pressure [ Time Frame: 12 months ]
  • Change from baseline in anti-hypertensive medication intake [ Time Frame: 12 months ]

Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: June 2016
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Percutaneous renal denervation Device: PARADISE percutaneous renal denervation
Intravascular ultrasound emission
Other Name: ReCor Medical PARADISE

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529372


Locations
France
Université de Toulouse et CHU
Toulouse, France, 1048
Hôpital Pitié-Salpêtrière
Paris, Île-de-France, France, 75013
Sponsors and Collaborators
ReCor Medical, Inc.
Investigators
Principal Investigator: Gilles Montalescot, Professor Hôpital Pitié-Salpêtrière
  More Information

Responsible Party: ReCor Medical, Inc.
ClinicalTrials.gov Identifier: NCT01529372     History of Changes
Other Study ID Numbers: CLIN-0020-HT
First Submitted: January 19, 2012
First Posted: February 8, 2012
Last Update Posted: April 6, 2016
Last Verified: November 2014

Keywords provided by ReCor Medical, Inc.:
Hypertension
Blood pressure
Renal denervation

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases