REnAL denervatIon by ultraSound Transcatheter Emission

Resistant Hypertension Clinical Trial

— REALISE  

Official title:

REnAL denervatIon by ultraSound Transcatheter Emission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529372
• Other study ID #: CLIN-0020-HT
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: March 2015

Study information

• Verified date: July 2018
• Source: ReCor Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

Device:
• PARADISE percutaneous renal denervation
Intravascular ultrasound emission

Locations

Country	Name	City	State
France	Hôpital Pitié-Salpêtrière	Paris	Île-de-France
France	Université de Toulouse et CHU	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
ReCor Medical, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 24 hours
Primary	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.)	12 months
Secondary	Change from baseline in ambulatory blood pressure		12 months
Secondary	Change from baseline in anti-hypertensive medication intake		12 months