Resistant HypertensionREALISENCT01529372
REnAL denervatIon by ultraSound Transcatheter Emission
A study testing PARADISE percutaneous renal denervation in people with Resistant Hypertension, run by ReCor Medical, Inc. at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- PARADISE percutaneous renal denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- May 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Currently participating in the study of an investigational drug or device
- Hemodynamics abnormality
- Moderate to severe renal insufficiency
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Pitié-Salpêtrière
Paris, Île-de-France Region, 75013
Université de Toulouse et CHU
Toulouse, 1048
About this study
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.
- Conditions
- Resistant Hypertension
- Being tested
- PARADISE percutaneous renal denervation
- Keywords
- Hypertension, Blood pressure, Renal denervation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARADISE percutaneous renal denervationDevice
Also called ReCor Medical PARADISE
Intravascular ultrasound emission
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous renal denervation | Experimental | Not described Receives: Device: PARADISE percutaneous renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of successful interventions
A successful intervention is defined by the ability to successfully:
- Introduce the PRDS catheter
- Position the PRDS catheter
- Deliver ultrasound energy
- Retrieve the PRDS catheter
Measured: 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.)
Measured: 12 months
Secondary outcomes (2)
Change from baseline in ambulatory blood pressure
Measured: 12 months
Change from baseline in anti-hypertensive medication intake
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReCor Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilles Montalescot, Professor, Principal investigator, Hôpital Pitié-Salpêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529372
- Sponsor's protocol ID
- CLIN-0020-HT
- Acronym
- REALISE
- Status last verified
- Jul 2018
- First submitted
- 19 Jan 2012
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REnAL denervatIon by ultraSound Transcatheter Emission
- ClinicalTrials.gov ID
- NCT01529372
- Acronym / sponsor ID
- REALISE / CLIN-0020-HT
- Conditions
- Resistant Hypertension
- Keywords
- Hypertension, Blood pressure, Renal denervation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ReCor Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous renal denervation | Experimental | Device: PARADISE percutaneous renal denervation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PARADISE percutaneous renal denervationAlso: ReCor Medical PARADISEIntravascular ultrasound emission | Device | Percutaneous renal denervation |
Primary outcome
Percentage of successful interventions
Time frame: Up to 24 hours
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
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.)
2 secondary outcomes
Change from baseline in ambulatory blood pressure
Time frame: 12 months
Change from baseline in anti-hypertensive medication intake
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Montalescot, Professor principal investigator
Hôpital Pitié-Salpêtrière
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PARADISE percutaneous renal denervation in people with Resistant Hypertension, run by ReCor Medical, Inc. at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of successful interventions (time frame: Up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.