Multi-Center, Single-Blind, Two-Arm, Randomized, Controlled, Non Inferiority Trial of the Conor CoStar Paclitaxel-Eluting Coronary Stent System vs the TAXUS DES in Patients With De Novo Lesions of the Native Coronary Arteries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,701
- 试验地点
- 4
- 主要终点
- MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent (TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent) in the treatment of single-vessel (one blood vessel) and multi-vessel (two or three blood vessels) coronary artery disease.
详细描述
Non -inferiority in 8-month Major Adverse Cardiac Events (MACE) and in-segment late lumen loss at 9 months between the CoStar™ Paclitaxel-Eluting Coronary Stent System and the TAXUS™ Express2™ Drug Eluting Coronary Stent System for the treatment of a single de novo lesion per vessel in patients with single and multi-vessel coronary disease.
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 (Participant)
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 (Class I, II, III or IV), documented ischemia, or documented silent ischemia
- •Documented LVEF ≥25% within the last 6 weeks.
- •Eligible for coronary artery bypass graft surgery (CABG)
排除标准
- •General Exclusion Criteria:
- •Known sensitivity to paclitaxel or polymeric matrices: Translute or PLGA.
- •Planned treatment with any other PCI device in the target vessel(s).
- •MI within 72 hours prior to the index procedure
- •Patient is in cardiogenic shock
- •Cerebrovascular Accident (CVA) within the past 6 months
- •Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150 µmol/L)
- •Contraindication to ASA or to clopidogrel
- •Thrombocytopenia
- •Active GI bleeding within past three months
- •Known allergy to stainless steel or cobalt chromium
- •Any prior true anaphylactic reaction to contrast agents
- •Patient is currently taking colchicine
结局指标
主要结局
MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death
时间窗: 8 months
In-segment late lumen loss
时间窗: 9 months
次要结局
- Device, lesion and procedure success(At procedure or hospital discharge)
- Incidence of MACE(30 days, 9 months and 12 months)
- Coronary angiography in the angiographic cohort(9 months)
- Target lesion revascularization(8 months)