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
  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:


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
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, see Learn About Clinical Studies.

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 August 18, 2014