RT Journal Article
SR Electronic
T1 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
JF Journal of NeuroInterventional Surgery
JO J NeuroIntervent Surg
FD BMJ Publishing Group Ltd.
SP 524
OP 529
DO 10.1136/neurintsurg-2020-016250
VO 13
IS 6
A1 Imamura, Hirotoshi
A1 Sakai, Nobuyuki
A1 Matsumoto, Yasushi
A1 Yamagami, Hiroshi
A1 Terada, Tomoaki
A1 Fujinaka, Toshiyuki
A1 Yoshimura, Shinichi
A1 Sugiu, Kenji
A1 Ishii, Akira
A1 Matsumaru, Yuji
A1 Izumi, Takashi
A1 Oishi, Hidenori
A1 Higashi, Toshio
A1 Iihara, Koji
A1 Kuwayama, Naoya
A1 Ito, Yasushi
A1 Nakamura, Masato
A1 Hyodo, Akio
A1 Ogasawara, Kuniaki
YR 2021
UL http://jnis.bmj.com/content/13/6/524.abstract
AB 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.Data are available upon reasonable request.