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.

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.
Competing Interests: Competing interests: HI received speakers’ bureau/honoraria from Medtronic Japan Co. and Stryker Japan Co. NS received speakers’ bureau/honoraria and research funding from Terumo Co. YM received speakers’ bureau/honoraria from GE Healthcare Co, Stryker Co, Medico’s Hirata Co, Medtronic Japan Co, Century Medical Co, Takeda Pharmaceutical Co, Otsuka Pharmaceutical Co, and Fuji Systems Co. HY received speakers’ bureau/honoraria from JIMRO Co, Terumo Co, Johnson & Johnson Co, Medtronic Japan Co, Medico’s Hirata Co, and Stryker Japan Co. SY received speakers’ bureau/honoraria from Terumo Co, Boehringer-Ingelheim Co, Daiichi Sankyo Co, Bayer Co, Bristol-Meyers Squibb Co, Stryker Japan Co, Medtronic Japan Co, Johnson & Johnson Co, Kaneka Medics Co, Otsuka Pharmaceutical Co, Biomedical Solutions Co, and Sanofi Co. AI received speakers’ bureau/honoraria from Medtronic Japan Co, Stryker Japan Co, Daiichi Sankyo Co, Otsuka Pharmaceutical Co, and Kaneka Medics Co. HO received speakers’ research funding from Terumo Co. TH received speakers’ bureau/honoraria from Stryker Japan Co, Johnson & Johnson Co, Kaneka Medics Co, and Terumo Co, and research funding from Stryker Japan Co. and Medtronic Japan Co. KI received research funding from the Japan Agency for Medical Research and Development, grants-in-aid, the Japan Ministry of Health, Labor and Welfare, KAKENHI grant from the Japan Society for the Promotion of Science, Otsuka Pharmaceutical Co, Eisai Co, and Kaneka Medics Co.
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