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REnAL denervatIon by ultraSound Transcatheter Emission (REALISE)

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ClinicalTrials.gov Identifier: NCT01529372
Recruitment Status : Unknown
Verified November 2014 by ReCor Medical, Inc..
Recruitment status was:  Active, not recruiting
First Posted : February 8, 2012
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
ReCor Medical, Inc.

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
Resistant Hypertension Device: PARADISE percutaneous renal denervation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Primary Completion Date : February 2015
Estimated Study Completion Date : June 2016

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



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 ]


Information from the National Library of Medicine

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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

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

Responsible Party: ReCor Medical, Inc.
ClinicalTrials.gov Identifier: NCT01529372     History of Changes
Other Study ID Numbers: CLIN-0020-HT
First Posted: February 8, 2012    Key Record Dates
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