NCT02392351

Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)

A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8 weeks when compared to a masked procedure (renal angiogram).

Detailed description

Prospective, multicenter, single blinded, randomized, controlled, pilot study. Subjects will be randomized to renal denervation treatment or masked renal angiogram procedure (2:1).

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Renal Denervation (Vessix)	Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator
DEVICE	Renal Angiography	Percutaneous renal angiography

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-09-07
• Completion: 2019-08-02
• First posted: 2015-03-19
• Last updated: 2021-02-11
• Results posted: 2019-10-04

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study