XIENCE PRIME Everolimus Eluting Coronary Stent Post Marketing Surveillance (PMS) in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 536
- 试验地点
- 1
- 主要终点
- Number of Participants With Subacute Stent Thrombosis (ST)
研究概览
简要总结
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.
详细描述
The primary objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation by Pharmaceuticals and Medical Devices Agency (PMDA).
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 with ischemic heart disease who are eligible for treatment with XIENCE PRIME Everolimus Eluting Stent
- •Patient provides Informed Consent Form
排除标准
- •If it is known at the time of index procedure that the patient is not able to return for the 8-month follow-up visit for angiogram and for the 1-year clinical follow-up, then the patient should not be registered in the PMS.
结局指标
主要结局
Number of Participants With Subacute Stent Thrombosis (ST)
时间窗: Subacute (>24 hours to 30 days)
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).
Number of Participants With Acute Stent Thrombosis (ST)
时间窗: Time Frame: Acute (0-24 hours)
Stent thrombosis was defined by Academic Research Consortium (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 Myocardial infarction (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).
Number of Participants With Late Stent Thrombosis (ST)
时间窗: Late (>30 days to 1 year)
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).
Total Number of Participants With Overall Stent Thrombosis
时间窗: 1 year post index procedure
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).
次要结局
- Success Rate: Percentage of Participants With Implant Success Rate by Device(Participants will be followed for the duration of hospital stay, an average of 5 days)
- Success Rate: Percentage of Participants With Procedural Success by Lesion(Participants will be followed for the duration of hospital stay, an average of 5 days)
- Number of Participants With Target Vessel Failure (TVF)(3 year post index procedure)
- Number of Participants With Target Lesion Revascularization (TLR)(3 year post index procedure)
- Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base)(Participants will be followed for the duration of hospital stay, an average of 5 days)
- Number of Participants With All Death/All MI/All Revascularization (DMR)(4 year post index procedure)
- Number of Participants With Target Vessel Failure(TVF)(4 year post index procedure)
- Number of Participants With Target Lesion Failure (TLF)(4 year post index procedure)
- Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)(4 year post index procedure)
- Number of Participants With Death or Myocardial Infarction (MI)(4 year post index procedure)
- Number of Participants With Cardiac Death or Myocardial Infarction (MI)(4 year post index procedure)
- Number of Participants With Target Lesion Revascularization(TLR)(4 year post index procedure)
- Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)(4 year post index procedure)
- Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)(4 year post index procedure)
- Number of Participants With Myocardial Infarction (MI)(4 year post index procedure)
- Number of Participants With Non-Target Vessel Revascularization (Non-TVR)(4 year post index procedure)
- Number of Participants With All Revascularization(4 year post index procedure)
- Percent Diameter Stenosis (%DS)(8 months post index procedure)
- Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)(1 year post index procedure)
- Number of Participants With Target Vessel Revascularization (TLR or TVR ( Non-TLR))(1 year post index procedure)
- Acute Gain: In-stent, In-segment(8 months post index procedure)
- Net Gain: In-stent, In-segment(8 months post index procedure)
- Late Loss(LL): In-stent, In-segment, Proximal, and Distal(8 months post index procedure)
- Number of Participants With Non-Target Lesion Revascularization (Non-TLR)(4 year post index procedure)
- Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))(4 year post index procedure)
- Number of Participants Experienced Bleeding(4 year post index procedure)