NCT02027870已完成不适用
A Prospective Multicenter Single-Arm Observational Registry Study to Assess the Safety and Efficacy of EXCEL-II With Sirolimus Eluting Stent for the Treatment of Patients With de Novo Coronary Artery . (CREDIT-III Trial)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 625
- 试验地点
- 1
- 主要终点
- The Target Lesion Failure(TLF) as the primary endpoint at 12-month
研究概览
简要总结
The study aims to further assess the safety, efficacy and the performance of its delivery system of the new generation Sirolimus-eluting stent of JWMS up to five years.
详细描述
- A prospective, a single set, multicenter clinical trial;
- The primary in situ in patients with coronary heart disease;
- The center of: 28 (the actual number of center shall prevail);The plan selected 621 patients;(where the total number of cases in 2.25 mm specification not less than 30 cases, 5 cases each specification of not less than 2.25 mm.)
- Clinical follow-up time points: 1 months, 6 months, 12 months and 18 months of a year and 2 years to 5 years follow-up; This test by an independent coronary angiography core laboratories, data management and statistical center, clinical end points to judge committee and clinical monitoring of all relevant clinical and imaging data collecting, sorting, statistical analysis and judgement.All the selected patients within five years continuous follow-up tracking (phone or outpatient follow-up), to observe the happening of adverse events to the forward of the second generation of EXCEL drug-eluting stents (des) system security to make more accurate and credible evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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.
- •Left main lesion, transplant vasculopathy and stent restenosis lesion;
- •Severe calcified lesion unable to predilate.
- •The distortion of the stent was hampered by lesions.
- •NYHA≥Ⅲ or LVEF<35%.
- •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
The Target Lesion Failure(TLF) as the primary endpoint at 12-month
时间窗: 12months
Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure
次要结局
- Stent implantation success rate(5 Years)
- TLF, cardiovascular composite endpoints, ARC defined stent thrombosis(30 days, 6 months, and 2-5 years)
研究者
研究点 (1)
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