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, Takashi Izumi, Hidenori Oishi, Toshio Higashi, Koji Iihara, Naoya Kuwayama, Yasushi Ito, Masato Nakamura, Akio Hyodo, Kuniaki Ogasawara

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

Background The dual-layer nitinol CASPER stent was designed to prevent plaque prolapse into its strut and periprocedural stroke. Objective To conduct a clinical trial for government approval of the device in patients at either high or normal risk for carotid endarterectomy (CEA). Methods Eligible 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. Results 140 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. Conclusions The 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.

Original languageEnglish
Pages (from-to)524-529
Number of pages6
JournalJournal of NeuroInterventional Surgery
Volume13
Issue number6
DOIs
Publication statusPublished - Jun 1 2021
Externally publishedYes

Keywords

  • angioplasty
  • cervical
  • stent

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

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