Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

REnAL denervatIon by ultraSound Transcatheter Emission (REALISE)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ReCor Medical, Inc. Identifier:
First received: January 19, 2012
Last updated: April 4, 2016
Last verified: November 2014
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

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 ]

Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: June 2016
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01529372

Université de Toulouse et CHU
Toulouse, France, 1048
Hôpital Pitié-Salpêtrière
Paris, Île-de-France, France, 75013
Sponsors and Collaborators
ReCor Medical, Inc.
Principal Investigator: Gilles Montalescot, Professor Hôpital Pitié-Salpêtrière
  More Information

Responsible Party: ReCor Medical, Inc. Identifier: NCT01529372     History of Changes
Other Study ID Numbers: CLIN-0020-HT 
Study First Received: January 19, 2012
Last Updated: April 4, 2016
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.:
Blood pressure
Renal denervation

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on January 14, 2017