Dataset Information

One-year outcomes of a novel venous stent for symptomatic iliofemoral venous obstruction: prospective cohort study.

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 < .001). The 12-month primary patency rate (91.36%; 95% CI, 85.93-95.19%; P < .001) exceeded the literature-defined performance goal. VCSS changes from baseline demonstrated clinical improvement at 6 months (- 4.30 ± 3.66) and 12 months (- 4.98 ± 3.67) (P < .001). Significant reduction in symptoms, as measured by CEAP C classification and CIVIQ-14, was observed from pre-procedure to 12 months (P < .001).

Conclusions

The 12-month outcomes confirm the safety and effectiveness of the V-Mixtent Venous Stent in managing symptomatic iliofemoral venous outflow obstruction, including clinical symptom improvement compared to before treatment.

SUBMITTER: Sheng C

PROVIDER: S-EPMC11304576 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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One-year outcomes of a novel venous stent for symptomatic iliofemoral venous obstruction: prospective cohort study.

Sheng Chang C Lu Xin-Wu XW Shi Hong-Tao HT Zhang Lei L Wan Sheng-Yun SY Li Hong-Pu HP Li Ke K Shi Sen S Liu Zhen-Jie ZJ Luo Yu-Xian YX Chen Guo-Dong GD Liu Mao-Rong MR Kang You-Gen YG Ye Bo B Yao Kai K Yang Pu P Wang Wei W

BMC medicine 20240807 1

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 39113028

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Dataset Information

One-year outcomes of a novel venous stent for symptomatic iliofemoral venous obstruction: prospective cohort study.

Background

Methods

Results

Conclusions

Publications

One-year outcomes of a novel venous stent for symptomatic iliofemoral venous obstruction: prospective cohort study.

Similar Datasets

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