NCT00322543终止3 期
Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID) A Multi-Center Study of the Pimecrolimus-Eluting Cobalt Chromium Coronary Stent System (Corio™) in Patients With De Novo Lesions of the Native Coronary Arteries
Conor Medsystems2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2006年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Angiographic endpoint of in-stent late lumen loss at 6 months
研究概览
简要总结
Non-randomized, single arm, multi-center, clinical trial evaluating the Corio™ pimecrolimus-eluting stent with reduced anti-platelet therapy in patients with de novo lesions of the native coronary arteries.
详细描述
The registry is designed to evaluate 6-month in-stent late lumen loss in patients receiving the Corio™ drug-eluting stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion Criteria
- •Eligible for percutaneous coronary intervention (PCI).
- •Documented stable or unstable angina pectoris
- •Left ventricular ejection fraction (LVEF) ≥25%
- •Acceptable candidate for coronary artery bypass graft surgery (CABG).
- •Target Lesion < 25 mm in length with RVD of 2.5 to 3.5 mm with visually estimated stenosis of >= 50 and < 100 %.
排除标准
- •General Exclusion Criteria
- •Known sensitivity to pimecrolimus, the polymer (PLGA) or cobalt chromium.
- •Planned treatment with any other PCI device in the target vessel(s).
- •MI within 72 hours prior to the index procedure
- •The patient is in cardiogenic shock.
- •Cerebrovascular Accident (CVA) within the past 6 months.
- •Acute or chronic renal dysfunction
- •Contraindication to ASA or to clopidogrel.
- •Thrombocytopenia
- •Active gastrointestinal (GI) bleeding within the past 3 months.
- •Any prior true anaphylactiod reaction to contrast agents
- •Patient is currently taking chronic systemic steroid therapy or systemic immunosuppressant therapy or topical pimecrolimus.
- •Female of childbearing potential.
- •Life expectancy of less than 24 months due to other medical conditions.
- •Co-morbid condition(s)
- •Currently participating in another investigational drug or device study
结局指标
主要结局
Angiographic endpoint of in-stent late lumen loss at 6 months
时间窗: 6 months
次要结局
- Major Adverse Cardiac Events (MACE) defined as an adjudicated composite of clinically driven target vessel revascularization, new myocardial infarction (MI) or cardiac death at 30 days, 6 months, 12 months and 2 years;(30 days, 6 months, 12 months and 2 years)
- Device, Lesion and Procedural Success; Coronary angiography at 6 months; IVUS measurements in IVUS cohort at 6 months.(6 months)
研究者
研究点 (2)
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