Ignite Creation Date:
2024-05-06 @ 2:21 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02027012
Status:
TERMINATED
Last Update Posted:
2020-09-14
First Post:
2014-01-01
Brief Title:
Treatment of Resistant Hypertension by Renal Denervation in China
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter in China
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
company strategic change
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REDUCE-HTN-CN
Brief Summary:
REDUCE-HTN-China study is a prospective multi-center single cohort study for the percutaneous therapeutic treatment of medication-resistant hypertension in ChinaThe primary objective is to assess the efficacy performance of the Vessix Renal Denervation System for the treatment of medication resistant hypertension on the basis of the hypothesis that the percutaneous therapeutic renal denervation for the treatment of medication-resistant hypertension using the Vessix Renal Denervation System will reduce systolic SBP and diastolic blood pressure DBP at 6- month compared to baseline as accessed by office-based blood pressure measurements
Detailed Description:
The Vessix System is a highly-differentiated and advanced renal denervation system that features an intuitive push-button interface a short 30-second treatment time and an over-the-wire balloon-based approach familiar to most cardiac and vascular specialists The Vessix System has both CE Mark and TGA approval and is currently available for sale in Europe the Middle East Australia New Zealand and selected markets in Asia The Vessix System is an investigational device and not available for sale in China An current analysis of the REDUCE-HTN post market study affirms the devices safety profile and effective treatment for resistant hypertension
Study Oversight
Has Oversight DMC:
None
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?:
None