The GORE® VIAFORT Vascular Stent IVC Study

Status Recruiting

Clinical Trial Summary

This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.

Clinical Trial Description

A maximum of 35 clinical investigative sites across the U.S., Europe, Australia, and New Zealand will participate in this study. One hundred and eleven subjects are intended to be implanted with the GORE® VIAFORT Vascular Stent in this study, with a limit of 22 treated subjects per site and a minimum of 45 patients treated within the United States. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months post-treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05409976
Study type	Interventional
Source	W.L.Gore & Associates
Contact	Carl Conway
Phone	6175952277
Email	cconway@wlgore.com
Status	Recruiting
Phase	N/A
Start date	October 25, 2022
Completion date	January 2029

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