NCT01541865

Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter

Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation device.

Detailed description

This study will evaluate the hypothesis that the Vessix V2 Renal Denervation System can be employed to reduce systolic and diastolic blood pressure at 6 months as compared to pre-treatment baseline blood pressures. Patient blood pressure will be measured by in the office according to recognized international techniques and standards. Procedural success shall be defined as ability to complete the renal denervation treatment using the V2 balloon catheter device and RF generator.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Renal Denervation	percutaneous renal denervation using the Vessix RF balloon catheter

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-11-01
• Completion: 2015-06-01
• First posted: 2012-03-01
• Last updated: 2015-11-25
• Results posted: 2015-10-16

Locations

26 sites across 8 countries: Australia, Austria, Belgium, France, Germany, Netherlands, New Zealand, Switzerland