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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01529372 |
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Date of registration:
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19/01/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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REnAL denervatIon by ultraSound Transcatheter Emission
REALISE |
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Scientific title:
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REnAL denervatIon by ultraSound Transcatheter Emission |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01529372 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Gilles Montalescot, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital Pitié-Salpêtrière |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Resistant Hypertension
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Intervention(s)
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Device: PARADISE percutaneous renal denervation
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Primary Outcome(s)
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Percentage of patients with device- or procedure-related adverse events
[Time Frame: 12 months]
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Percentage of successful interventions
[Time Frame: Up to 24 hours]
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Secondary Outcome(s)
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Change from baseline in anti-hypertensive medication intake
[Time Frame: 12 months]
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Change from baseline in ambulatory blood pressure
[Time Frame: 12 months]
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Secondary ID(s)
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CLIN-0020-HT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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