NCT00569491已完成4 期
TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,585
- 试验地点
- 50
- 主要终点
- Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee
研究概览
简要总结
The TAXUS ARRIVE study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low frequency TAXUS related clinical events.
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
- •Appropriate Patient Criteria:
- •Patient is eligible to receive a Boston Scientific TAXUS Stent.
- •Inappropriate Patients Criteria:
- •Known sensitivity to paclitaxel.
- •Known allergy to stainless steel.
- •Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated.
- •Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.
- •Patients with unresolved vessel thrombus at the lesion site.
- •Patients with coronary artery reference vessel diameters < 2.5 mm or > 3.75 mm.
- •Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation.
- •Patients with diffuse disease or poor overflow distal to the identified lesions.
- •Patients with tortuous vessels in the region of the obstruction or proximal to the lesion.
- •Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.
排除标准
- 未提供
结局指标
主要结局
Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee
时间窗: 1 year post-implant procedure
次要结局
- Rate of target vessel related cardiac events as classified by the Clinical Events Committee(30 days, 6 months, 1 and 2 years post-implant procedure)
- Rate of other TAXUS related events(30 days, 6 months, 1 and 2 years post-implant procedure)
- Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee(30 days, 6 months, 2 years post-implant procedure)
研究者
研究点 (50)
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