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              SERY


              垠藝?藥物支架療效安全性多中心注冊研究
              Safety and Efficacy Registry of Yinyi? stent (SERY)

              研究類別:前瞻性臨床注冊
              主要研究者:沈衛峰 教授、朱國英 教授
              承擔單位:上海交通大學醫學院附屬瑞金醫院、湖北武漢亞洲心臟病醫院
              研究贊助單位:遼寧生物醫學材料研發中心有限公司
              CRO:北京美華醫信科技有限公司
              Core Lab:上海交通大學醫學院心血管病研究所

              受試支架

              垠藝?無聚合物微盲孔載藥(紫杉醇)冠脈支架

              患者數目

              共入選患者1045例。

              研究目的

              1)隨訪觀察術后12個月不良心臟事件(MACE)
              2)觀察急性和亞急性和晚期血栓形成
              3)術后9~12個月血管造影評價垠藝?支架再狹窄發生率及晚期管腔丟失
              4)評價支架的推送能力、側枝保護能力、徑向支撐力及X 線可視性
              5)評價支架與血管形狀適應性和覆蓋病變能力

              主要終點

              術后12、24、36個月的主要不良心臟事件(MACE)
              MACE 包括:死亡、再梗死及靶病變再次血運重建率。

              次要終點

              1.術后12個月血栓事件(ARC定義)
              2.術后9~12個月的再狹窄率及晚期管腔丟失

              研究進展

              SERY研究是垠藝?無聚合物微盲孔載藥(紫杉醇)冠脈支架2008年上市后的第一個大型臨床研究,也是當時國際上入選病例最多的無聚合物涂層藥物支架臨床研究。全國共有27家研究參與單位,入選病例數1045個,植入1713個垠藝?支架。研究的主要終點及次要終點的12、24、36個月隨訪結果,已分別在2010、2011、2012年的長城國際心臟病學會議上進行了報告,結果令人振奮。

              由于無聚合物涂層藥物支架具有的全新載藥技術特點,使其藥物釋放更加適合真實疾病治療和組織愈合機制的要求,可以在有效控制再狹窄的基礎上提高支架內皮化及功能化速度,沒有永久聚合物涂層藥物支架的晚期追趕現象(Late Catch-up)、晚期血栓等后遺癥, 為患者帶來長期安全和全面效應,SERY研究顯示垠藝TM無聚合物微盲孔載藥冠脈支架兼具藥物支架的有效性和金屬裸支架的安全性。

              五分时时彩

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