NCT00731237已完成不适用
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,517
- 试验地点
- 43
- 主要终点
- Overall physician-determined XIENCE V® EECSS acute performance and deliverability.
研究概览
简要总结
This trial is to assess physician-determined XIENCE V® EECSS acute performance, deliverability and resource utilization in the catheterization lab during commercial use by various physicians with a range of coronary stenting experience
详细描述
This study will evaluate overall physician-determined XIENCE V® Everolimus Eluting Coronary Stent system (XIENCE V®) acute performance, deliverability and resource utilization in the catheterization lab in the "real world" as used by a broad group of physicians at a variety of health care facilities. This study will include all consecutively enrolled patients in the United States of America (USA) who consent to participate and receive XIENCE V® stents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient agrees to participate in this study by signing the IRB approved informed consent form prior to the index procedure.
- •Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form prior to the index procedure.
排除标准
- •Inability to obtain an informed consent is an exclusion criterion.
结局指标
主要结局
Overall physician-determined XIENCE V® EECSS acute performance and deliverability.
时间窗: acute
Physician-determined procedure success
时间窗: acute
次要结局
- Individual component of adjunctive devices and drugs used during procedure. Number and type of guide wires(acute)
- Individual component of adjunctive devices and drugs used during procedure. Number and type of guiding catheters(acute)
- Individual component of adjunctive devices and drugs used during procedure. Number and type of balloon dilation catheters(acute)
- Individual component of adjunctive devices and drugs used during procedure: Balloon pressures (pre-dilation/post-dilation pressures)(acute)
- Individual component of adjunctive devices and drugs used during procedure: Number of stents(acute)
- Individual component of adjunctive devices and drugs used during procedure: Amount of radiographic contrast(acute)
- Individual component of adjunctive devices and drugs used during procedure: Fluoroscopy time(acute)
- Individual component of adjunctive devices and drugs used during procedure: Duration of PCI procedure(acute)
- Individual component of adjunctive devices and drugs used during procedure: IVUS use(acute)
- Individual component of adjunctive devices and drugs used during procedure: Thienopyridine loading dose (prior to, during or after procedure)(acute)
- Individual component of adjunctive devices and drugs used during procedure: Aspirin loading dose (prior to, during or after procedure)(acute)
- Device Success(acute)
研究者
研究点 (43)
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