Study for Investigate the Effectiveness and Safety of Resolute Integrity or Xience Prime in Diabetes or Small Vessels Lesion Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- in-segment late lumen loss (mm)at 12month
研究概览
简要总结
The newer generation ZES (Medtronic, Minneapolis, MN, Resolute Integrity) and EES (Abbott Vascular, Abbott Park, Illinois, Xience Prime) were introduced to South Korea. Although these are thought to be superior in effect and stability compared to ZES and EES of previous generation, there are few clinical data regarding the high risk groups of diabetes patients or small vessels lesion. Moreover, looking at the 8.3% of restenosis in Resolute All Comer study (23% diabetes), the investigators could not know the outcome in high risk patients such as diabetes or small vessels lesion. Therefore, the aim of this study is to investigate the effectiveness and safety of Resolute Integrity or Xience Prime in diabetes or small vessels lesion patients.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patients requiring stent procedure (visual diameter stenosis ≥ 50%)
- •Stable angina with evidence of myocardial ischemia, acute coronary syndrome(ST segment elevation, non-ST segment elevation acute myocardial infarction, and unstable angina)
- •Patients diagnosed of type 2 diabetes or small vessel disease
- •Patients willing to participate in the study through written consent
排除标准
- •Those hypersensitive to or abstaining from heparin, aspirin, clopidogrel, contrast medium, zotarolimus, or everolimus.
- •Pregnant women or those having future plans for pregnancy.
- •Those having hemorrhagic disease or blood-clotting disorders (including heparin-induced thrombocytopenia), or those rejecting blood transfusion.
- •Those having medical history of digestive and urinary system bleeding during the last 3 months, or who have received major surgery within 2 months.
- •Those with thrombocytopenia (< 100,000/mm3) or hemoglobin 10.0 g/dL or less.
- •Those planning a surgery that requires the discontinuation of antiplatelet drugs within next 12 months (especially, thienopyridines type).
- •When the remaining survival period is expected to be less than 1 year.
- •Restenosis lesion
- •Left main coronary artery lesion
- •Saphenous vein graft stenosis lesion
- •Left ventricular ejection fraction < 30%
- •Cardiac shock
- •Those with liver function failure: When liver enzyme level (ALT) is 3 times the normal upper limit.
- •Type I diabetes
结局指标
主要结局
in-segment late lumen loss (mm)at 12month
时间窗: 12month
次要结局
- major adverse cardiac events(MACE) at 12month(12month)
- MACE at 24month(24month)
- procedure success rate(1 day (after procedure))
研究者
Lae Young Jung
Doctor
Chonbuk National University Hospital