NCT02027012

Treatment of Resistant Hypertension by Renal Denervation in China

Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter in China

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

REDUCE-HTN-China study is a prospective, multi-center, single cohort study for the percutaneous therapeutic treatment of medication-resistant hypertension in China.The 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 device's safety profile and effective treatment for resistant hypertension.

Conditions

• Medication-resistant Hypertension

Interventions

Type	Name	Description
DEVICE	Percutaneous renal denervation with the Vessix™ Renal Denervation System

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-03-01
• Completion: 2015-09-01
• First posted: 2014-01-03
• Last updated: 2020-09-14

Locations

1 site across 1 country: China