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

NCT02392351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-02-11

Study results available
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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).

Conditions

Interventions

DEVICE

Renal Denervation (Vessix)

Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator

DEVICE

Renal Angiography

Percutaneous renal angiography

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Martin B Leon, MD · Columbia University

  • Michael Weber, MD · SUNY Downstate College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-09-07
Completion
2019-08-02
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02392351 on ClinicalTrials.gov