A retrospective multicenter clinical trial of Venastent for patients with Iliac Vein Compression Syndrome.

Abstract

Objective: To evaluate the safety and efficacy of Venastent for the patients with Iliac Vein Compression Syndrome (IVCS).

Methods: A multi-center retrospective clinical trial enrolling 199 IVCS patients was conducted by the department of vascular surgery of three hospitals from October 2021 to January 2023. Among them, 91 were treated with a new type of iliac vein stent and defined as the experimental group; and 108 cases in the control group were using Zilver Vena venous stent (Cook Medical). 12-month follow-up was performed for the following primary endpoints: the patency rate, the venous clinical severity score (VCSS) and the CEAP classification.

Results: To validate the role of Venastent in the prevention of thrombosis, 91 patients with Venastent vs 108 patients with control stent were compared. No difference was found on the demographic data, or accompanying symptoms or disease severity scores between the 2 groups of patients. The patency rates of the contralateral deep vein at 24 months after the surgery were 100.00 vs 94.5% respectively (P=0.043). Moreover, no difference was found on the VCSS score and CEAP classification of the both groups.

Conclusions: Venastent with a large corolla-like mesh and an adequate radial force shows a good patency in the ipsilateral iliac vein and could prevent thrombosis in the contralateral iliac vein.