We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 9 for:    REALISE trial
Previous Study | Return to List | Next Study

REnAL denervatIon by ultraSound Transcatheter Emission (REALISE)

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.
 
ClinicalTrials.gov Identifier: NCT01529372
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
ReCor Medical, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Resistant Hypertension Device: PARADISE percutaneous renal denervation Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: REnAL denervatIon by ultraSound Transcatheter Emission
Study Start Date : May 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Percutaneous renal denervation Device: PARADISE percutaneous renal denervation
Intravascular ultrasound emission
Other Name: ReCor Medical PARADISE


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  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 Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Gilles Montalescot, Professor Hôpital Pitié-Salpêtrière
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: ReCor Medical, Inc.
ClinicalTrials.gov Identifier: NCT01529372    
Other Study ID Numbers: CLIN-0020-HT
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Keywords provided by ReCor Medical, Inc.:
Hypertension
Blood pressure
Renal denervation
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases