JPRN-UMIN000006940已完成3 期
CLINICAL EVALUATION OF NEW TERUMO DRUG ELUTING CORONARY STENT SYSTEM IN THE TREATMENT OF PATIENTS WITH CORONARY ARTERY DISEASE - CENTURY II Trial
Terumo Europe N.V.0 个研究点目标入组 1,120 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.not a suitable candidate for DAPT, 2.known allergy to sirolimus, everolimus, cobalt, chromium, nickel, or contrast agent, 3.Most recent LVEF of the patient is not more than 25%, 4.PLT count is less than 100K cells/mm3 or more than 700K cells/mm3, 5.WBC count is less than 3,500 cells/mm3, 6.Cerebral hemorrhage within 180 days prior to the baseline procedure, 7.Active peptic ulcer or upper GI bleeding within 180 days prior to the baseline procedure, 8.The patient has bleeding diathesis or coagulopathy, 9.Any planned future PCI, 10.currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints, 11. n the investigator's opinion patient has (a) co-morbid conditions(s) that could limit patients's abilibility to participate in the study, compliance with FU requiements or impact the scientific integrity of the study,12.in cardiogenic shock, 13.Life expectancy less than 1 year, 14.renal failure requiring dialysis, 15.female of child-bearing potential, 16.under judicial protection (only for France) Additional Exclusion criteria for COHORT A 1.not less than 20 years old (in Japan only), 2.Target vessel reference D requires stent of 4.0 mm D (in Japan only), 3.AMI within 48 hours before baseline procedure, 4.Previous PCI with stenting (within 30 days), 5.Previous stenting within the TL, 6.refuse a blood transfusion, 7.a widespread peripheral vascular disease that would interfere with vascular access, 8.The TL(s) has any of the following characteristics, a)Bifurcation lesion that need stenting of main and side branch, b) Ostial lesion, c) TL is located in or supplied by an arterial or venous bypass graft, d) TL would require vessel preparation other than balloon-predilatation, 9.TL is located in left main trunk, 10.More than one lesion per vessel and more than 2 vessels disease
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