Evidence map›Paper›PMID 39365550›Full record

Trial reportCardiovascular intervention and therapeutics2025

Safety and efficacy assessment of the Inno-Xmart venous stent system in managing symptomatic iliofemoral venous obstruction: a 12-month outcome analysis.

Chong Yu, Xiaoming Zhang, Xiaoyan Gong, Min Zhou, Yi Hong, Bin Zhou, Guojun Chen, Xiang Wang

Abstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Cardiovascular intervention and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Chong YuDepartment of Vascular Surgery, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, 200120, China.
Xiaoming ZhangDepartment of Vascular Surgery, Peking University People's Hospital, Peking University, Beijing, China.
Xiaoyan GongSuzhou Innomed Medical Device Co., Ltd., Jiangsu, China.
Min ZhouSuzhou Innomed Medical Device Co., Ltd., Jiangsu, China.
Yi HongDepartment of Vascular Surgery, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, 200120, China.
Bin ZhouDepartment of Vascular Surgery, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, 200120, China.
Guojun ChenDepartment of Vascular Surgery, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, 200120, China.
Xiang WangDepartment of Vascular Surgery, Shanghai East Hospital, School of Medicine, Tongji University, Shanghai, 200120, China. rad_wangxiang@hotmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study aims to evaluate the safety and efficacy of the dedicated Inno-Xmart braided venous stent system (Suzhou Innomed Medical Device Co., Ltd., Jiangsu, China) in treating symptomatic iliofemoral venous obstruction. This clinical study followed a prospective, multicentre, single-arm design with the application of an objective performance goal. Patients diagnosed with symptomatic iliofemoral venous obstruction who met the eligibility criteria of this study were enrolled and treated with the Inno-Xmart venous stent system. The safety endpoints included the assessment of stent fracture, satisfaction of delivery system and 12-month incidence rate of major adverse events (MAEs). The primary efficacy endpoint focused on evaluating the 12-month primary patency rate through venography as determined by core laboratory. Secondary efficacy endpoints included surgical success rate, 6-month primary patency rate and the changes in quality of life from baseline to 6- and 12-month follow-up intervals. Between September 18, 2019, and April 26, 2021, 193 patients were successfully enrolled across 18 research institutions. The surgical success rate was 95.3% (184/193), the 12-month MAE rate was 5.1% (9/178) with no stent fractures or migrations. The 12-month primary patency rate for the participants was 96.1%, significantly surpassing the literature-derived objective performance of 80% (95% confidence interval [CI], 92.1-98.4; P < 0.0001). In addition, the mean venous clinical severity score (VCSS) and Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) scores at the 6- and 12-month follow-ups were significantly lower than the preoperative scores (P < 0.001). The innovative, dedicated braided venous stent designed to address symptomatic iliofemoral venous obstruction demonstrates a high technical success rate, low complication rates, and impressive mid-term (12-month) patency. It effectively enhanced the quality of life for patients and holds promising prospects for a wide range of applications. The clinical study was officially registered in the "Chinese Clinical Trial Registry" (Registration number: ChiCTR2000040216, date of registration: November 25th, 2020).

Indexed as

Endovascular ProceduresFemoral VeinIliac VeinStentsAdultAgedFemaleHumansMaleMiddle AgedProspective StudiesQuality of LifeTreatment OutcomeVascular PatencyAcute deep vein thrombosisIliofemoral venous obstructionInno-Xmart venous stentNonthrombotic iliac vein lesionPost-thrombotic syndrome

Identifiers

PMID39365550

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.