Evidence map›Paper›PMID 40404296›Full record

Trial reportJournal of neurointerventional surgery2026

A hydrogel vascular closure device for hemostasis after transfemoral intervention: a randomized controlled clinical trial.

Shuhong Yu, Zhichao Huang, Zhimai Lyu, Min Li, Bo Ye, Guoyong Zeng, Jiaping Xu, Huaishun Wang, Jie Hou, Yuehui Liu and 3 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of neurointerventional surgery, 2026. 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

13 authors.

Shuhong Yu *Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Zhichao Huang *Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Zhimai LyuDepartment of Neurology, The First Affiliated Hospital of Gannan Medical University, Ganzhou, China.
Min LiJiangsu Province Hospital of Chinese Medicine, Nanjing, Jiangsu, China.
Bo YeDepartment of Vascular Surgery, Ganzhou People's Hospital, Ganzhou, China.
Guoyong ZengDepartment of Neurology, Ganzhou People's Hospital, Ganzhou, China.
Jiaping XuDepartment of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Huaishun WangDepartment of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Jie HouDepartment of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Yuehui LiuDepartment of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Yage ZhaoDepartment of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Zhiliang GuoDepartment of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China yarrowshaw@hotmail.com guozhiliang3@163.com.ORCID http://orcid.org/0000-0003-3898-7739
Guodong XiaoDepartment of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China yarrowshaw@hotmail.com guozhiliang3@163.com.ORCID http://orcid.org/0000-0003-2674-5505

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn this randomized controlled trial we aim to validate the efficacy and safety of a hydrogel vascular closure device (VCD) for hemostasis after transfemoral intervention.

methodsBetween January and August 2023, 212 patients were enrolled, including 202 in a non-inferiority randomized controlled trial (1:1 hydrogel vs ExoSeal; prespecified margin -10%) and 10 in a hydrogel-only observational arm (8 F). The primary endpoint was device success rate and secondary endpoints including hemostasis time and procedural blood loss.

resultsAmong 102 hydrogel and 100 ExoSeal recipients, hydrogel had non-inferior success rates (99.02% vs 94.00%; 95% CI -0.27% to 11.74%). Hydrogel achieved significantly faster hemostasis (1.99 vs 3.14 min, P<0.001) and reduced blood loss (0.83 mL vs 8.93 mL, P<0.001). No major access site complications were observed in either group. No secondary complications occurred in patients in the experimental group and secondary complications occurred in one patient in the control group (P=0.497). The supplementary cohort of 10 patients supported the efficacy and safety of hydrogel VCD.

conclusionsHydrogel VCD shows non-inferior efficacy to ExoSeal for transfemoral cerebrovascular interventions, with superior hemostatic speed and reduced blood loss while maintaining comparable safety. TRIAL REGISTRATION NUMBER: ChiCTR2300068029 (https://www.chictr.org.cn/showproj.html?proj=178962).

Indexed as

Femoral ArteryHemostasisHemostatic TechniquesHydrogelsVascular Closure DevicesAdultAgedFemaleHumansMaleMiddle AgedTreatment OutcomeHydrogelsArteryBrainInterventionMaterialTechnique

Identifiers

PMID40404296
PMCPMC13217100

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.