NCT02360709Unknown不适用
A Prospective, Multi-center, Single-arm Observational Registry Trial Evaluating the Safety and Efficacy of CRE8 Sirolimus-Eluting Stent in the Treatment of Patients With De Novo Coronary Artery Lesions
CID S.p.A.1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2014年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Target lesion failure (TLF,device-oriented endpoint)
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent system in the treatment of patients with de novo coronary artery lesions.
详细描述
This is a prospective, multi-center, single-arm observational registry trial planned to enroll 800 subjects. All 800 subjects enrolled will receive CRE8 stents. Clinical follow-up will be performed at 1 month, 6 months,12 months and annually up to 5 years after the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age ≥18 years and ≤ 75 years, male or female without pregnancy;
- •Patients with clinical evidence of asymptomatic heart disease, stable or unstable angina, or old myocardial infarction;
- •De novo lesions of native coronary arteries;
- •Target vessel diameter between 2.25mm and 4.5 mm, and target lesion length ≤ 60mm by visual estimation;
- •Target lesion diameter stenosis ≥ 70% by visual estimation;
- •Each target lesion must be implanted the same stent (CRE8);
- •Patients is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG);
- •Patients with left ventricular ejection fraction ≥40%;
- •Patients who can understand the nature of the study, agree to participate and accept angiographic and clinical follow-up, and have provided written informed consents.
排除标准
- •Patients with acute myocardial infarction (AMI) within 72 hours;
- •Chronic total occlusion lesion (TIMI flow 0 before procedure), Left main disease and/or triple-vessel lesion that might require treatment;
- •Heavily calcified or tortuous lesions which cannot be successfully pre-dilated, and lesions which are not suitable for stent delivery and deployment;
- •In-stent restenosis;
- •Thrombotic lesions;
- •Patients who had received any other stent in the past one year;
- •Patients with acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
- •Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or with a history of active gastrointestinal bleeding, ulcer, cerebral hemorrhage or subarachnoid hemorrhage and stroke within 6 months;
- •Patients who allergic to aspirin, clopidogrel, ticagrelor, ticlopidine, heparin, contrast agent, sirolimus, polymer, Co-Cr alloy, or with contraindication to aspirin or clopidogrel or ticagrelor;
- •Patients with life expectancy less than 1year;
- •Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
- •Patient is in the opinion of the investigator, unable to comply with the requirements of the study protocol;
- •Patients who had underwent heart transplant surgery.
结局指标
主要结局
Target lesion failure (TLF,device-oriented endpoint)
时间窗: 12months after the procedure
次要结局
- Target lesion failure (TLF,device-oriented endpoint)(1month,6months,2years,3years,4years and 5years follow-up)
- The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularizations(1month,6months,12months and annually up to 5years follow-up)
- Stent thrombosis per ARC definition(1month,6months,12months and annually up to 5years follow-up)
- device and lesion success rates(immidiately after the procedure)
- clinical success rate(7 days after the procedure)
研究者
研究点 (1)
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