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              YINYI-EPCI


              垠藝?無聚合物載藥冠脈支架與雷帕霉素涂層藥物洗脫支架急診PCI的多中心、隨機對照臨床研究
              A Multicenter, Randomized Trial of YINYI? Polymer-Free Paclitaxel - Eluting Stent vs. Polymer Sirolimus - Eluting Stent in the Emergency PCI

              臨床研究申辦單位:遼寧生物醫學材料研發中心有限公司
              臨床研究主要承擔機構:首都醫科大學北京朝陽醫院
              臨床研究負責人:王樂豐 教授

              受試支架

              試驗組支架:垠藝?無聚合物微盲孔載藥(紫杉醇)冠脈支架
              對照組支架:雷帕霉素涂層藥物洗脫支架(Firebird 2, Partner, Excel及其他國產支架)

              患者數目

              兩組共需入選患者1584例。
              試驗組和對照組的分配比為3:1,試驗組=1188例;對照組=396例。

              研究目的

              本研究的主要目的是以i-TLR為主要研究終點,與雷帕霉素涂層藥物洗脫支架對比,評價垠藝?無聚合物微盲孔載藥(紫杉醇)冠狀動脈支架在治療急診冠狀動脈病變方面的非劣效性。

              作為急診治療,效率也是重要的相關因素,本研究把手術成功率(分別關注由于器械通過性和病變本身引起的影響因素)和急診治療效率(分別記錄發病—入院;入院—導管室;導管室—開通血管的時間;集合計算入院—開通血管的時間),分析各中心的急診治療的時間效率及影響因素。(開通血管以導絲、球囊擴開血管一刻為準)

              此外,以ARC定義的血栓發生率、復合安全性終點、TVR和TVF等為次級研究終點,與雷帕霉素涂層藥物洗脫支架對比,評價垠藝?無聚合物微盲孔載藥(紫杉醇)冠狀動脈支架治療急診冠狀動脈病變的安全性和有效性;并通過進行亞組分析,評價垠藝?無聚合物微盲孔載藥(紫杉醇)冠狀動脈支架在亞組人群中(如糖尿病等)的安全性和有效性。

              主要終點

              1年的癥狀驅使型靶病變血運重建(i-TLR)

              次要終點

              1)手術成功率(分別記錄由于器械通過性和病變本身引起的影響因素);
              2)急診治療效率(分別記錄發病—入院;入院—導管室;導管室—開通血管的時間;集合計算入院—開通血管的時間),分析各中心的急診治療的時間效率及影響因素;
              3)ARC定義下的"確定+可能"的支架血栓事件(包括急性、亞急性及晚期);
              4)詳細記錄患者DAPT用藥劑量和調整時間點,特別關注對因特殊情況提前停用抗血小板藥物患者的支架血栓事件;
              5)30天、6個月及1年的主要不良心臟事件(Major Adverse Cardiac Events, MACE);
              6)30天、6個月及1年的總死亡和心源性死亡;
              7)30天、6個月及1年的由心源性死亡、所有心肌梗死及支架血栓組成的復合安全性終點,特別記錄每個隨訪時間點由于患者自身疾病狀況導致提前停用抗血小板藥物的原因和支架血栓組成的復合安全性;
              8)30天、6個月及1年的靶血管血運重建(TVR)及靶血管失敗(TVF)。TVF定義為:與靶血管相關的死亡、再次心肌梗死(Q波和非Q波),以及靶血管血運重建(Re-PCI或CABG)。

              研究進展

              敬請期待!

              五分时时彩

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