1. One-year outcomes of a novel venous stent for symptomatic iliofemoral venous obstruction: prospective cohort study
- Author
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Chang Sheng, Xin-Wu Lu, Hong-Tao Shi, Lei Zhang, Sheng-Yun Wan, Hong-Pu Li, Ke Li, Sen Shi, Zhen-Jie Liu, Yu-Xian Luo, Guo-Dong Chen, Mao-Rong Liu, You-Gen Kang, Bo Ye, Kai Yao, Pu Yang, Wei Wang, and on behalf of the Trial Investigators
- Subjects
Venous stenting ,Iliofemoral venous outflow obstruction ,Patency ,Multicenter study ,Clinical improvement ,Medicine - Abstract
Abstract Background A stent with characteristics of a hybrid design may have advantages in improving the patency of symptomatic iliofemoral vein obstruction. This study assessed the safety and effectiveness of the V-Mixtent Venous Stent in treating symptomatic iliofemoral outflow obstruction. Methods Eligible patients had a Clinical-Etiologic-Anatomic-Physiologic (CEAP) C classification of ≥ 3 or a Venous Clinical Severity Score (VCSS) pain score of ≥ 2. The primary safety endpoint was the rate of major adverse events within 30 days. The primary effectiveness endpoint was the 12-month primary patency rate. Secondary endpoints included changes in VCSS from baseline to 6 and 12 months, alterations in CEAP C classification, Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-14) scores at 12 months, and stent durability measures. Results Between December 2020 and November 2021, 171 patients were enrolled across 15 institutions. A total of 185 endovenous stents were placed, with 91.81% of subjects receiving one stent and 8.19% receiving 2 stents. Within 30 days, only two major adverse events occurred (1.17%; 95% confidence interval [CI], 0.14–4.16%), below the literature-defined performance goal of 11% (P
- Published
- 2024
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