Evidence map›Paper›PMID 40425281›Full record

Observational studyJournal of neurointerventional surgery2026

Efficacy and safety of a new mechanical balloon-based flow diverter in the treatment of intracranial aneurysms.

Jingwei Li, Wei Ni, Yiran Lu, Li Li, Chuan He, Chao Gao, Tianxiao Li, Xinjian Yang, Hongqi Zhang

Abstract readObservational StudyMulticenter Study
In one paragraph

Observational study 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 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
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

9 authors.

Jingwei Li *Department of Neurosurgery, Xuanwu Hospital, Beijing, China.ORCID http://orcid.org/0000-0002-2620-3389
Wei Ni *Department of Neurosurgery, Fudan University Huashan Hospital, Shanghai, China.ORCID http://orcid.org/0000-0002-9550-3430
Yiran Lu *AccuMedical Inc, Beijing, China.
Li LiNeurosurgery Department of Stroke Center, Henan Provincial People's Hospital, Zhengzhou, China.
Chuan HeDepartment of Neurosurgery, Xuanwu Hospital, Beijing, China.
Chao GaoDepartment of Neurosurgery, Fudan University Huashan Hospital, Shanghai, China.
Tianxiao Li *Neurosurgery Department of Stroke Center, Henan Provincial People's Hospital, Zhengzhou, China.
Xinjian Yang *Department of Interventional Neuroradiology, Beijing Neurosurgical Institute, Beijing, China.
Hongqi Zhang *Department of Neurosurgery, Xuanwu Hospital, Beijing, China xwzhanghq@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFlow diverters (FDs) are the first-line treatment of intracranial aneurysms (IAs). A groundbreaking mechanical balloon-based FD device was developed to enhance the precise landing and deployment efficiency for FDs.

objectiveTo investigates the efficacy and safety of this innovative device in a prospective cohort.

methodsThis study was a prospective multicenter observational study conducted between September 2019 and November 2021. Patients diagnosed with unruptured IAs and treated with this innovative FD device alone were included. The immediate implantation success rate, the successful aneurysm occlusion rate (Raymond I-II or OKM C-D), the complete occlusion rate (Raymond I or OKM D), and the parent artery stenosis rate (>50%) at follow-up were evaluated as the evaluation index of efficacy. The mortality rate, adverse events (AEs), neurological AEs, and serious adverse events (SAEs) were evaluated as the evaluation index of safety.

resultsA total of 128 patients were included, and all of the FD deployments were successful (success rate reached 100%). At the 12-month mark, 91.4% (117/128) of patients achieved successful occlusion, 85.9% (110/128) achieved complete occlusion, and only 0.8% (1/128) exhibited parent artery stenosis >50% (without need for additional treatment). During the follow-up, there were no reported mortalities or cerebral hemorrhage, while 6 neurological adverse events (4.69%) and 4 SAEs (3.1%) were observed.

conclusionsThe mechanical balloon-based FD showed a remarkable occlusion rate alongside minimal ischemic and hemorrhagic adverse events compared with existing FDs. This innovative mechanical balloon-based design may be an important direction for future FD design.

Indexed as

Balloon OcclusionEndovascular ProceduresIntracranial AneurysmAdultAgedFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeAneurysmDeviceFlow DiverterTechnique

Identifiers

PMID40425281
PMCPMC13217126

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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.