REWARDS (Registry Experience at the Washington Hospital Center, DES - Xience V)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,069
- 试验地点
- 1
- 主要终点
- Evaluation of Major Adverse Cardiac Events (MACE) post Xience V implantation
研究概览
简要总结
Single center registry of patients who have received a Xience V everolimus-eluting stent at the Washington Hospital Center, with the primary objective to assess clinical success and safety at 30 days, 6 months and 1 year post-implantation.
详细描述
Interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (BMS) and recently with the drug-eluting stents (DES). The everolimus eluting, Xience V stents have shown very promising results in randomized clinical trials, demonstrating a reduction of clinical and angiographic restenosis in comparison to BMS, and comparable clinically-driven target lesion revascularization rates in comparison with sirolimus-eluting stents. While registry data is available from outside of the United States, it will be important to collect "real-world" data regarding the stent usage and outcomes in the United States. In this study we propose to follow patients who received at least one Xience V® Stent for at least 1 year post initial stent implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients, male or female, >18 years of age
- •Patients who received at least one Xience V drug-eluting stent at the Washington Hospital Center
排除标准
- •Patients who received another type of DES (other than Xience V) or a bare metal stent at the time of initial Xience V stent implantation
结局指标
主要结局
Evaluation of Major Adverse Cardiac Events (MACE) post Xience V implantation
时间窗: Follow Up
次要结局
未报告次要终点
研究者
Rebecca Torguson
Director, ACRO
Medstar Health Research Institute