Evaluating venous stent performance: an overview of pivotal clinical trials.

Authors

Mahmood K Razavi, Theodore Bryan, Crystal Razavi

Published in

The Journal of cardiovascular surgery. Nov 12, 2026. Epub Nov 12, 2026.

Abstract

The aim of this article is to summarize the results of the pivotal studies to obtain USA Food and Drug Administration approval for dedicated venous stents. This article reviews the results of the five completed pivotal trials in venous stents for iliofemoral obstructions The results of the VIRTUS, VIVO, VERNACULAR, ABRE, VIVID, and FORTEGA trials were reviewed and tabulated. Variations in trial design and outcome are analyzed and results summarized. Across studies, overall primary patency rates approach 85-90% at one year, with significant improvements in venous symptoms and quality of life. Results of the pivotal dedicated venous stent trials confirmed safety and efficacy of these devices in treating patients with ilio-femoral venous outflow obstruction.

PMID:
43018471
Bibliographic data and abstract were imported from PubMed on 12 Nov 2026.

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