REnAL denervatIon by ultraSound Transcatheter Emission

Not Applicable

Completed

• Conditions: Resistant Hypertension
• Interventions: Device: PARADISE percutaneous renal denervation

• Registration Number: NCT01529372
• Lead Sponsor: ReCor Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-08
• Study Start: 2012-05
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-05
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Percutaneous renal denervation	PARADISE percutaneous renal denervation	-

Primary Outcome Measures

Name	Time	Method
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.)
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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in anti-hypertensive medication intake	12 months
Change from baseline in ambulatory blood pressure	12 months

Trial Locations

Locations (2)

Université de Toulouse et CHU; 🇫🇷 Toulouse, France

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, Île-de-France, France