NCT01348399已完成不适用
Evaluation of Effectiveness and Safety of XIENCE PRIME™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Seung-Jung Park29 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2011年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 29
- 主要终点
- composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
研究概览
简要总结
The objective of this study is to evaluate effectiveness and safety of XIENCE PRIME stent in the "real world" daily practice as compared with other drug eluting stents (DESs)
详细描述
This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of XIENCE PRIME stents versus other DESs in patients with coronary artery disease.
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
- •Patients receiving XIENCE PRIME stents.
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
排除标准
- •Patients with a mixture of other DESs
- •Terminal illness with life expectancy <1 year
- •Patients presented with cardiogenic shock
结局指标
主要结局
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
时间窗: 12 months post procedure
次要结局
- Death (all cause and cardiac)(yearly up to 5 years)
- MI(yearly up to 5 years)
- TVR(yearly up to 5 years)
- Target-lesion revascularization (TLR)(yearly up to 5 years)
- Stent thrombosis (ARC criteria)(yearly up to 5 years)
- Composite of death or MI(yearly up to 5 years)
- Composite of cardiac death or MI(yearly up to 5 years)
- Procedural success (defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization)(At discharge from the index hospitalization)
研究者
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea
研究点 (29)
Loading locations...
相似试验
进行中（未招募）
不适用
Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical PracticeCoronary DiseaseCoronary Artery DiseaseNCT03967158Seung-Jung Park2,000
已完成
不适用
Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After StentingCoronary Artery DiseaseNCT00960648Seoul National University Hospital3,056
已完成
不适用
EXCEL Clinical TrialChronic Coronary OcclusionUnprotected Left Main Coronary Artery DiseaseStent ThrombosisVascular DiseaseCoronary Artery StenosisCoronary DiseaseCoronary RestenosisCoronary Artery DiseaseMyocardial IschemiaNCT01205776Abbott Medical Devices1,905
进行中（未招募）
不适用
IRIS-Onyx Cohort in the IRIS-DES RegistryArterial Occlusive DiseasesCardiovascular DiseasesPercutaneous Transluminal AngioplastyCoronary Artery DiseaseNCT02593994Seung-Jung Park4,500
招募中
不适用
Evaluation of Effectiveness and Safety of Xience Skypoint Stents in Routine Clinical PracticeCoronary Artery DiseaseNCT05981911Seung-Jung Park2,000