主动脉覆膜支架系统的临床试验设计与考虑因素的探讨

      The Exploration of Design and Consideration Factors of Aortic Stent Graft System Clinical Trial

      • 摘要: 主动脉疾病是一种凶险的急危重症心血管疾病,病死率极高。近年来,进行腔内治疗的主动脉覆膜支架应用越来越广泛,开发新型主动脉覆膜支架也成为心血管医疗器械研发的热点。如何进行合理、科学的临床试验是主动脉覆膜支架系统设计确认的关键环节,应考虑主动脉疾病的病变性质、部位、节段、适用人群、生物力学等因素,并对有效性和安全性研究终点、设计类型等进行合理的设定。

         

        Abstract: Aortic disease is a dangerous and critical cardiovascular disease with a high mortality rate. In recent years, aortic stent grafts for endovascular treatment have become widely used, and the development of new aortic stent grafts has been a hot spot for cardiovascular medical devices. How to carry out a reasonable and scientific clinical trial is the key in the design confirmation of aortic stent graft system. The nature, location, segment, applicable population, biomechanics and other factors of aortic disease should be considered. The effectiveness and safety endpoint, trial design type should be carefully and reasonably studied.

         

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