Twelve-month end point results from the evaluation of the Zilver Vena venous stent in the treatment of symptomatic iliofemoral venous outflow obstruction (VIVO clinical study).

Background: In the present study, we evaluated the safety and effectiveness of the Zilver Vena venous stent in the treatment of patients with symptomatic iliofemoral outflow obstruction.

Methods: The VIVO clinical study was a prospective, nonrandomized, multicenter study that enrolled patients with symptomatic obstruction of one iliofemoral venous segment. Included were patients with Clinical, Etiological, Anatomical, Pathophysiological (CEAP) clinical classification of ≥3 or a Venous Clinical Severity Score (VCSS) pain score of ≥2.