NCT00415961终止不适用
Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety
Conor Medsystems2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2006年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- In-segment late lumen loss at 9 months, as measured by QCA.
研究概览
简要总结
This trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.
详细描述
This is a complementary, multi-center, open-label, single-arm trial investigating angiographic and clinical patient outcomes in Japan. Historical data from the 2-arm randomized COSTAR II trial will be used for comparison.
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
- 20 Years 至 95 Years（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.
- •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 ticlopidine
- •Thrombocytopenia
- •Active GI bleeding within past three months
- •Known allergy to cobalt chromium
- •Any prior true anaphylactic reaction to contrast agents
结局指标
主要结局
In-segment late lumen loss at 9 months, as measured by QCA.
时间窗: 9 months
次要结局
- Device, lesion and procedure success; MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months(MACE at 30 days and 8 months, Angiographic restenosis at 9 months; Clinically driven Target Lesion Revascularization at 8 months)
研究者
研究点 (2)
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