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REnAL denervatIon by ultraSound Transcatheter Emission (REALISE)

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention
Resistant Hypertension
 Device: PARADISE percutaneous renal denervation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: REnAL denervatIon by ultraSound Transcatheter Emission

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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.)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529372

Contacts
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

Locations
France
Hôpital Pitié-Salpêtrière Recruiting
Paris, Île-de-France, France, 75013
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    
Principal Investigator: Gilles Montalescot, Professor            
Sub-Investigator: Xavier Girerd, Professor            
Sub-Investigator: Philippe Cluzel, Professor            
Sponsors and Collaborators
ReCor Medical, Inc.
Investigators
Principal Investigator: Gilles Montalescot, Professor Hôpital Pitié-Salpêtrière
  More Information

No publications provided

Responsible Party: ReCor Medical, Inc.
ClinicalTrials.gov Identifier: NCT01529372     History of Changes
Other Study ID Numbers: CLIN-0020-HT
Study First Received: January 19, 2012
Last Updated: February 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: French Data Protection Authority
France: The Commission nationale de l’informatique et des libertés

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013