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一项在欧盟实施的临床试验表明,Endurant覆膜支架系统能够被安全地输送和植入。同时,针对该临床试验不良事件的认真回顾分析表明,腹主动脉瘤(AAA)腔内支架植入术具有可接受的安全性。这一试验使其获得CE认证而在欧洲市场上市。而另一项为期5年随访的IDE临床试验正在美国实施。
A clinical trial conducted in the European Union shows that Endurant covered stent systems can be safely delivered and implanted. In the meantime, careful review and analysis of adverse events in this trial indicate that abdominal AAA (endovascular stent graft) has acceptable safety. This test allows it to obtain CE certification in the European market. Another 5-year follow-up IDE clinical trial is being implemented in the United States.