XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,034
- 试验地点
- 1
- 主要终点
- Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)
研究概览
简要总结
XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are
- To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and
- To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.
详细描述
Among patients enrolled in the XIENCE V USA who have completed Study Phase I, some will be eligible to participate in the XIENCE V USA Long Term Follow-up (LTF) Cohort. This LTF cohort is a prospective, open-label, multi-center, observational, single-arm study is designed to evaluate XIENCE V EECSS continued safety and effectiveness in real world settings from 1 year after the index procedure up to 5 years. The XIENCE V USA LTF cohort will consist of the following from the initial 5,000 patients:
- The first 1,500 on-label patients who are treated in accordance with the XIENCE V EECSS Instruction for Use (IFU), and consecutively enrolled in the XIENCE V USA study
- The remaining patients who do not participate in the HCRI-DAPT cohort
- Data monitoring committee up to two years
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 Institutional Review Board approved informed consent form.
排除标准
- •The inability to obtain an informed consent.
- •Age limit is determined by investigator.
- •There are no angiographic inclusion or exclusion criteria for this study.
结局指标
主要结局
Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Consortium)
时间窗: 3 years
Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).
Stent Thrombosis (Definite and Probable) as Defined by ARC
时间窗: 4 years
Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (\>24 hours to 30 days post stent implantation), late (\>30 days to 1 year post stent implantation), or very late (\>1 year post stent implantation).
Composite Rate of Cardiac Death and Any Myocardial Infarction [MI] (ARC Defined).
时间窗: 2 years
Composite Rate of Cardiac Death and Any Myocardial Infarction (ARC Defined).
时间窗: 4 years
次要结局
- Any MI (Q-wave and Non Q-wave)(4 years)
- Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)(4 years)
- Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)(4 years)
- Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)(4 years)
- Major Bleeding Complications(4 years)
- Major Bleeding Complications (Site Reported)(3 years)
- Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)(4 years)
- Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)(4 years)
- Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG](4 years)
- Dual Antiplatelet Medication Usage(4 years)