REnAL denervatIon by ultraSound Transcatheter Emission

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01529372

Acronym

REALISE

Enrollment

Registered

2012-02-08

Start date

2012-05-31

Completion date

2015-03-31

Last updated

2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resistant Hypertension

Keywords

Hypertension, Blood pressure, Renal denervation

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.

Interventions

DEVICEPARADISE percutaneous renal denervation

Intravascular ultrasound emission

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of successful interventions	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	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.)

Secondary

Measure	Time frame
Change from baseline in anti-hypertensive medication intake	12 months
Change from baseline in ambulatory blood pressure	12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026