REnAL denervatIon by ultraSound Transcatheter Emission
REALISE
1 other identifier
interventional
20
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2012
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2012
CompletedFirst Posted
Study publicly available on registry
February 8, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJuly 6, 2018
July 1, 2018
2.8 years
January 19, 2012
July 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of successful interventions
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
Up to 24 hours
Percentage of patients with device- or procedure-related adverse events
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.)
12 months
Secondary Outcomes (2)
Change from baseline in ambulatory blood pressure
12 months
Change from baseline in anti-hypertensive medication intake
12 months
Study Arms (1)
Percutaneous renal denervation
EXPERIMENTALInterventions
Intravascular ultrasound emission
Eligibility Criteria
You may qualify if:
- Resistant hypertension, as defined in the 2007 ESH-ESC guidelines
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Université de Toulouse et CHU
Toulouse, 1048, France
Hôpital Pitié-Salpêtrière
Paris, Île-de-France Region, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilles Montalescot, Professor
Hôpital Pitié-Salpêtrière
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2012
First Posted
February 8, 2012
Study Start
May 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
July 6, 2018
Record last verified: 2018-07