REnAL denervatIon by ultraSound Transcatheter Emission (REALISE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by ReCor Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
ReCor Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01529372
First received: January 19, 2012
Last updated: February 8, 2013
Last verified: February 2013

January 19, 2012
February 8, 2013
May 2012
July 2014   (final data collection date for primary outcome measure)
  • Percentage of successful interventions [ Time Frame: Up to 24 hours ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

    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.)
Same as current
Complete list of historical versions of study NCT01529372 on ClinicalTrials.gov Archive Site
  • Change from baseline in ambulatory blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in anti-hypertensive medication intake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
REnAL denervatIon by ultraSound Transcatheter Emission
REnAL denervatIon by ultraSound Transcatheter Emission

The REALISE trial is a single-arm, open-label, prospective, first-in-man study to be conducted on twenty (20) eligible patients with a twelve month follow-up period.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Resistant Hypertension
Device: PARADISE percutaneous renal denervation
Intravascular ultrasound emission
Other Name: ReCor Medical PARADISE
Experimental: Percutaneous renal denervation
Intervention: Device: PARADISE percutaneous renal denervation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Xavier Girerd, Professor 01 42 17 78 33 xavier.girerd@psl.aphp.fr
Contact: Gilles Montalescot, Professor 01 42 16 30 07 gilles.montalescot@psl.aphp.fr
France
 
NCT01529372
CLIN-0020-HT
No
ReCor Medical, Inc.
ReCor Medical, Inc.
Not Provided
Principal Investigator: Gilles Montalescot, Professor Hôpital Pitié-Salpêtrière
ReCor Medical, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP