Evidence map›Paper›PMID 32934139›Full record

Trial reportJournal of neurointerventional surgery2021

Clinical trial of carotid artery stenting using dual-layer CASPER stent for carotid endarterectomy in patients at high and normal risk in the Japanese population.

Hirotoshi Imamura, Nobuyuki Sakai, Yasushi Matsumoto, Hiroshi Yamagami, Tomoaki Terada, Toshiyuki Fujinaka, Shinichi Yoshimura, Kenji Sugiu, Akira Ishii, Yuji Matsumaru and 9 more

Open access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of neurointerventional surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.8field-weighted citation impact, top 7% of its field
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

19 citing papers in PubMed, 35 citations in OpenAlex.

  1. Article
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  6. Current Status of Carotid Artery Stenting.Interventional radiology (Higashimatsuyama-shi (Japan) · 2024
    Review
  7. Intraprocedural and Delayed Plaque Protrusion in Carotid Artery Stenting Using a Dual-Layer Metallic Stent.Journal of the Society for Cardiovascular Angiography & Interventions · 2024
    Article
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  16. Review
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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

19 authors at 18 institutions in 1 country.

Hirotoshi ImamuraDepartment of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan i-hiro@zg7.so-net.ne.jp.ORCID http://orcid.org/0000-0001-8923-7861
Nobuyuki SakaiDepartment of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan.
Yasushi MatsumotoDepartment of Neuroendovascular Therapy, Kohnan Hospital, Sendai, Japan.
Hiroshi YamagamiDivision of Stroke Care Unit, National Cerebral and Cardiovascular Center, Suita, Japan.
Tomoaki TeradaDepartment of Neurosurgery, Showa University Fujigaoka Hospital, Yokohama, Japan.
Toshiyuki FujinakaDepartment of Neurosurgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Shinichi YoshimuraDepartment of Neurosurgery, Hyogo College of Medicine, Nishinomiya, Japan.
Kenji SugiuDepartment of Neurosurgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Akira IshiiDepartment of Neurosugery, Kyoto University, Kyoto, Japan.
Yuji MatsumaruDivision of Stroke prevention and treatment, Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Takashi IzumiDepartment of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Hidenori OishiDepartment of Neurosurgery, Juntendo University, Faculty of Medicine, Tokyo, Japan.
Toshio HigashiDepartment of Neurosurgery, Fukuoka University School of Medicine, Fukuoka, Japan.
Koji IiharaDepartment of Neurosurgery, Kyushu University, Graduate School of Medical Sciences, Fukuoka, Japan.
Naoya KuwayamaDepartment of Neurosurgery, University of Toyama, Toyama, Japan.
Yasushi ItoDepartment of Neurosurgery, Shinrakuen Hospital, Niigata, Japan.
Masato NakamuraToho University Ohashi Medical Center, Tokyo, Japan.
Akio HyodoDepartment of Neurosurgery, Dokkyo Medical University Koshigaya Hospital, Koshigaya, Japan.
Kuniaki OgasawaraDepartment of Neurosurgery, Iwate Medical University, Morioka, Japan.
Kobe City Medical Center General Hospital · JPDokkyo Medical University Saitama Medical Center · JPFukuoka University · JPHyogo Medical University · JPIwate Medical University · JPJuntendo University · JPKohnan Hospital · JPKyoto University · JPKyushu University · JPNagoya University · JPNational Cerebral and Cardiovascular Center · JPOkayama University · JPOsaka National Hospital · JPShinrakuen Hospital · JPShowa University Fujigaoka Hospital · JPToho University · JPUniversity of Toyama · JPUniversity of Tsukuba · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe dual-layer nitinol CASPER stent was designed to prevent plaque prolapse into its strut and periprocedural stroke.

objectiveTo conduct a clinical trial for government approval of the device in patients at either high or normal risk for carotid endarterectomy (CEA).

methodsEligible patients had ≥50% symptomatic stenosis or ≥80% asymptomatic stenosis according to the North American Symptomatic Carotid Endarterectomy Trial methods (peak systolic velocity 130 and 230 cm/s on ultrasonography, respectively). The primary endpoint was the lack of major adverse events (MAEs), defined as death, stroke, and myocardial infarction within 30 days, and ipsilateral stroke within 1 year. The performance goal was set at 90.5%. MAE rates were also compared between the CEA high- and normal-risk groups.

results140 carotid artery stenting procedures, including 40% of patients at high risk and 60% at normal risk for CEA, were performed in 13 institutes. MAEs occurred in two cases (one intraprocedural and one postprocedural stroke), and the MAE rate was 1.4%. The non-MAE rate was 98.6% according to Kaplan-Meier analysis, which was superior to the previously set performance goal. The deployment success, target lesion revascularization (TLR), in-stent restenosis, and cerebrovascular event rates were 99.3%, 2.4%, 8.5%, and 7.2%, respectively. The MAE rate in patients with normal CEA risk was 1.2%, which was similar to the high-risk CEA group, with no significant difference due to the small number of MAEs.

conclusionsThe MAE rate following use of the CASPER stent was low (1.4%). The MAE, deployment success, TLR, in-stenosis, and cerebrovascular event rates were similar to those of previous reports.

Indexed as

AgedAged, 80 and overCarotid ArteriesCarotid StenosisEndarterectomy, CarotidFemaleHumansJapanMaleMiddle AgedRisk FactorsSelf Expandable Metallic StentsTime FactorsTreatment Outcomeangioplastycervicalstent

Identifiers

PMID32934139
PMCPMC8142440
OpenAlexW3085386253

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

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.