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REnAL denervatIon by ultraSound Transcatheter Emission (REALISE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ReCor Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01529372
First received: January 19, 2012
Last updated: November 24, 2014
Last verified: November 2014

January 19, 2012
November 24, 2014
May 2012
February 2015   (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, post market evaluation 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.
 
Active, not recruiting
20
February 2015
February 2015   (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 information is only displayed when the study is recruiting subjects
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.
November 2014

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