A Prospective Multicenter Randomized Trial to Assess the Safety and Effectiveness of EXCEL-II vs. EXCEL Sirolimus Eluting Stent for the Treatment of Patients With de Novo Coronary Artery Lesions .( CREDIT II Trial )
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 1
- 主要终点
- 9 months in-stent late lumen loss
研究概览
简要总结
The purpose of this Randomized Study to evaluate the safety and efficacy of the Excel-II DES compared to the EXCEL DES in the treatment of patients with de novo coronary artery lesions.
详细描述
The primary end point is to observe in-stent late lumenn loss after 9 months of the stent implantation.
This study is based on non-inferior assumption (vs. EXCEL-II V EXCEL Stent), requring all of end points reach statictic significance.
Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 未提供
排除标准
- •AMI within 7 days.
- •CTO (TIMI 0), the left main lesion, ostial lesion and transplant vascular lesions, the bifurcation lesion (reference collateral blood vessel diameter of 2.5 mm or higher), stent restenosis lesions and to deal with three pathological changes;
- •Severe calcified lesion unable to predilate.
- •The distortion of the stent was hampered by lesions.
- •NYHA≥Ⅲ or LVEF<40%.
- •Prior PCI within 1 year.
- •Pregnancy or lactation, and planning pregnancy or lactation.
- •Subjects have bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue to take DAPT at least 1 year.
- •There are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (< 1 year).
- •To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
- •Serious liver and kidney function are not complete subject(ALT and AST were three times greater than the upper limit of normal).
- •Before enrolling to participate in other clinical trials and not reached the primary endpoint.
- •Non-compliant subject and could not finish the trial in accordance with the requirements of the subjects.
结局指标
主要结局
9 months in-stent late lumen loss
时间窗: 9 months
To observe in-stent late lumen loss after 9 months of stent implantation
次要结局
- Device success rates , lesion success rates , clinical success rates Device, lesion, & clinical success rates Device, lesion, & clinical success rates Target Lesion Failure(1m,6m,9m,12m,18m and annually to 5years)
- 9-m in-segment diameter restenosis rate(9 months)
- Rate of stent thrombosis(1m,6m,9m,12m,18m and annually up to 5 yrs)