Overview

This trial is active, not recruiting.

Condition resistant hypertension
Treatment paradise percutaneous renal denervation
Sponsor ReCor Medical, Inc.
Start date May 2012
End date February 2015
Trial size 20 participants
Trial identifier NCT01529372, CLIN-0020-HT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
paradise percutaneous renal denervation ReCor Medical PARADISE
Intravascular ultrasound emission

Primary Outcomes

Measure
Percentage of successful interventions
time frame: Up to 24 hours
Percentage of patients with device- or procedure-related adverse events
time frame: 12 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title REnAL denervatIon by ultraSound Transcatheter Emission
Principal investigator Gilles Montalescot, Professor
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by ReCor Medical, Inc..