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
  Purpose

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 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: February 2015
Estimated Primary Completion Date: February 2015 (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

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
  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: November 24, 2014
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

ClinicalTrials.gov processed this record on May 21, 2015