Prospective rAndomized, Single-blind, multicenTral Control Clinical Trial of Sirolimus-eluting coRonary Stent "Calypso" (Angioline) vs Everolimus-elutIng cOronary stenT "Xience Prime" (Abbott Vascular)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 610
- 试验地点
- 2
- 主要终点
- Target lesion failure
研究概览
简要总结
The aim of the study is to evaluate the efficacy and safety of sirolimus-eluting coronary stent "Calypso" (Angioline, Russia) in comparison with everolimus-eluting coronary stent "Xience" (Abbott Vascular, USA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients considered for coronary angioplasty with stenting due to Ischemic heart disease (Stable angina, Unstable angina, non-ST Myocardial Infarction).
- •Target vessel lesion in coronary artery with diameter measurements >2.5 mm & < 4.5 mm.
- •Signed, documented informed consent prior to admission to the study
排除标准
- •Age <18 years or >75 years
- •Renal insufficiency (GFR/MDRD <30 ml/min)
- •Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm
- •Known non-adherence to DAPT
- •LVEF <30%
- •Known oncology
- •Severe cardiac valvular pathology, requiring operative treatment within 1 year
- •Anemia (HB<100 g/l)
- •Continuing bleeding
- •Acute coronary syndrome (ST-elevation Myocardial infarction)
- •Anamnesis of previous coronary angioplasty/stenting or CABG
- •NYHA class (dyspnoea) IV or hospitalization during last year due to Chronic cardiac failure as a primary diagnosis.
- •Pregnancy
- •Coronary pathology requiring CABG or staged scheduled coronary angioplasty/stenting except cases of unscheduled staged coronary angioplasty/stenting within 4 weeks after primary procedure.
研究组 & 干预措施
Sirolimus-eluting stent "Calypso"
Commercially approved coronary stent system "Calypso" (Angioline, Russia) Coating - Sirolimus(rapamicine) Stent diameters: 2.0, 2.25, 2.5, 2.75, 3.0, 3.5, 4.0, 4.5 mm. Stent lengths: 8, 13, 15, 18, 23, 28, 33, 38 mm.
干预措施: DES "Calypso" (Device)
Sirolimus-eluting stent "Calypso"
Commercially approved coronary stent system "Calypso" (Angioline, Russia) Coating - Sirolimus(rapamicine) Stent diameters: 2.0, 2.25, 2.5, 2.75, 3.0, 3.5, 4.0, 4.5 mm. Stent lengths: 8, 13, 15, 18, 23, 28, 33, 38 mm.
干预措施: Coronary angioplasty (Procedure)
Everolimus-eluting stent "Xience Prime"
Commercially approved XIENCE PRIME, (Abbott Vascular, USA) Coating - Everolimus with concentration Stent diameters: 2.25, 2.5, 2.75, 3.0, 3.5, 4.0 mm. Stent lengths: 8, 12, 15, 18, 23, 28, 33, 38 mm.
干预措施: DES "Xience Prime" (Device)
Everolimus-eluting stent "Xience Prime"
Commercially approved XIENCE PRIME, (Abbott Vascular, USA) Coating - Everolimus with concentration Stent diameters: 2.25, 2.5, 2.75, 3.0, 3.5, 4.0 mm. Stent lengths: 8, 12, 15, 18, 23, 28, 33, 38 mm.
干预措施: Coronary angioplasty (Procedure)
结局指标
主要结局
Target lesion failure
时间窗: during 1 year after procedure
Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.
次要结局
- 1 year major adverse cardiac and cerebrovascular events (MACCE)(during 1 year after procedure)