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              FREEDOM


              對比垠藝?無聚合物微盲孔載藥冠脈支架與雷帕霉素永久涂層藥物洗脫支架的安全性和有效性的前瞻性、多中心、隨機對照臨床研究
              A Prospective, Multicenter, Randomized Trial of YINYI? Polymer-Free Paclitaxel-Eluting Stent vs. Durable Polymer Sirolimus-Eluting Stent in the Treatment of Coronary Artery Disease (FREEDOM)

              臨床研究申辦單位:遼寧生物醫學材料研發中心有限公司

              臨床試驗組織機構:
              (1) 主要研究者:霍勇 教授 北京大學第一醫院
              (2) 專家執行委員會(按姓氏拼音排序)
                 委 員:
                  陳紀言 教授 廣東省人民醫院
                  杜志民 教授 中山大學附屬第一醫院
                  葛均波 教授 復旦大學附屬中山醫院
                  韓雅玲 教授 沈陽軍區總醫院
                  呂樹錚 教授 首都醫科大學附屬北京安貞醫院
                  沈衛峰 教授 上海交通大學醫學院附屬瑞金醫院
                  楊躍進 教授 中國醫學科學院阜外心血管病醫院
                  朱國英 教授 湖北亞洲心臟病醫院
                 秘書長:
                  徐波 主任 中國醫學科學院阜外心血管病醫院
              (3) 臨床事件判定委員會
              (4) 冠狀動脈造影核心實驗室:永銘誠道(北京)醫學科技股份有限公司
              (5) 數據管理:永銘誠道(北京)醫學科技股份有限公司
              (6) 數據統計:衛生部心血管病防治研究中心生物統計部
              (7) 數據安全和監察負責人:李衛研究員
              (8) 臨床監查:北京怡和智策咨詢有限公司

              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:雷帕霉素永久涂層藥物洗脫支架(Cypher, Firebird 2, Partner)

              患者數目

              兩組共入選患者1626例。
              試驗組和對照組的分配比為2:1,試驗組=1084 例;對照組=542例。

              研究目的

              本研究的主要目的是以TVF為主要研究終點,與雷帕霉素永久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冠狀動脈病變方面的總體安全性和有效性。

              此外,以ARC定義的血栓發生率、復合安全性終點、TVR 和TLR等為次級研究終點,與雷帕霉素永久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?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年的靶血管失敗率(Target Vessel Failure, TVF).
              TVF定義為:與靶血管相關的死亡、心肌梗死(Q波和非Q波),以及靶血管再次血管重建(Re-PCI或CABG)。

              次要終點

              1) ARC定義下的"確定+可能"的支架血栓事件(包括早期、晚期及遲發晚期)
              2) 30天、1年及2年的主要不良心臟事件(Major Adverse Cardiac Events, MACE)
              3) 30天、1年及2年的總死亡和心源性死亡
              4) 30天、1年及2年的由心源性死亡、所有心肌梗死及腦血管意外組成的復合安全性終點
              5) 30天、1年及2年的靶血管再次血管重建(TVR)及靶病變再次血管重建(TLR)

              研究進展

              FREEDOM研究是國際上首個隨機對照無聚合物紫杉醇支架和永久涂層雷帕霉素支架的大型臨床研究,其1年隨訪結果顯示:兩組間主要終點TVF無顯著性差異 (P=0.3714),6個月后趨勢線兩者逐漸靠近,顯示其有效性基本相同。次要終點TVR、血栓及復合安全性終點等指標均無顯著性差異。說明具有長期安全優勢的無聚合物藥物支架,其有效性是值得信任的。

              五分时时彩

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