Clinical Trial Program of a Medical Instrument Product
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- In-stent late loss at 9-month
研究概览
简要总结
A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.
详细描述
A single blind, multi-center, randomized study is preformed to compare NOYA CoCr biodegradable coating sirolimus-eluting stents with Firebird2 drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd. to evaluate the safety and efficacy of NOYA CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions. Appropriate patients judged by inclusion and exclusion standards will be preformed stent implantation, and after that all patients will be clinically followed up at 30, 90, 180, 270,365 days,2 years,3 years,4 years and 5 years. Especially, standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents. Major adverse cardiac events (MACEs) found in following-up period as key indicators to evaluate the safety of stents. The arrangement, conclusion and statistical analysis of trial data including clinography and angiography will be fulfilled by independent Data Management Center(DMC) and radiography core laboratory.
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 (Outcomes Assessor)
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
- •Age 18-75 years, men or unpregnant women;
- •Angina pectoris patients with non-symptom myocardial ischemia, or patients with obsolete myocardial infarction;
- •Total of lesion artery ≤2;
- •Lesion artery ≤30 mm in length, 2.25 to 4.0 mm in diameter (ocular estimate);
- •Narrow level of lesion artery ≥70% in diameter (ocular estimate);
- •Amount of same stents implanted in a lesion artery ≤2;
- •Patients with indications of coronary artery bridging surgery(coronary artery bypass transplant technique);
- •Patients knowing about the objective of trial, willing to sign a statement of informed consent and join in this trial, and willing to accept follow-up.
排除标准
- •Patients with acute myocardial infarction in 7 days;
- •Chronic total occlusion lesions(TIMI 0 grade blood flow prior to implantation), left trunk vessel lesion, three-branch lesions needing treated, fork and bridge vessel lesions of branch vessels whose diameter ≥2.25mm;
- •Severe calcific lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents;
- •In-stent restenosis lesions;
- •Patients with stent implantation in his/her coronary artery within recent one year;
- •Severs heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)< 40%( supersonic inspection or left ventricular radiography );
- •Kidney functional damage prior to implantation, serum creatinine level>2.0mg/dl;
- •Patients with hemorrhage tendency, an active digestive ulcer history, a cerebral hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a year, and these patients who contraindicate against platelet inhibitors and anticoagulant therefore can not bear anticoagulation treatment;
- •Patients allergic to aspirin, clopidogrel or ticlopidine, heparin, contrast medium, rapamycin and metals;
- •Patients whose life expectancy less than 12 months;
- •Patients who are participating in other drugs or medical devices clinical trials;
- •Patients who can not comply with the clinical trial protocol;
- •Patients having a heart transplant.
结局指标
主要结局
In-stent late loss at 9-month
时间窗: 270 days (±30days)
Standard quantity coronary angiography (QCA) will be conducted at 270 days (±30days) through which the main therapeutic indicator of late luminal loss (LLL) is obtained so as to evaluate the efficacy of tested stents.
次要结局
- MACEs found in follow-up period(5 years)