Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-04 @ 10:43 PM
Study NCT ID:
NCT01834118
Status:
COMPLETED
Last Update Posted:
2016-07-28
First Post:
2013-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reintervention-study After Previous Renal Denervation in Non-responding Patients With Severe Hypertension
Sponsor:
Cardiovascular Center Frankfurt
Organization:
Study Overview
Official Title:
Reintervention After Previous Renal Denervation in Non-responding Patients With Severe Hypertension
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETREAT
Brief Summary:
The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used.
Detailed Description:
Renal Denervation is a CE-certified opportunity for treating patients with therapy-refractory hypertension. In some patients it doesn't show a significant lowering of the blood pressure, so a repeated renal denervation is an option.
In this study repeated renal denervation will be performed with the Recor Paradise Ultrasound Catheter.
For the study no specific procedures are required which would exceed the standard renal denervation procedure with the CE-certified Recor Paradise Ultrasound Catheter System.
There are no additional risks for the patient in consequence of participating in the study or the follow up procedures.
In this study repeated renal denervation will be performed with the Recor Paradise Ultrasound Catheter.
For the study no specific procedures are required which would exceed the standard renal denervation procedure with the CE-certified Recor Paradise Ultrasound Catheter System.
There are no additional risks for the patient in consequence of participating in the study or the follow up procedures.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: