Medication-resistant Hypertension Clinical Trial
Official title:
Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter in China
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.
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. ;