NCT03217877已完成不适用
a Multi-center, Open-label, Nationwide Registry-based, Randomized, Pragmatic Trial Comparing 2 Post-PCI Management Strategies in High-risk PCI Patients With Complex Clinical and Lesion Characteristics
Seung-Jung Park11 个研究点 分布在 1 个国家目标入组 1,700 人开始时间: 2017年11月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,700
- 试验地点
- 11
- 主要终点
- composite of major cardiovascular events
研究概览
简要总结
The primary objective of the POST-PCI trial is to compare the clinical outcomes of a post-percutaneous coronary intervention(PCI) aggressive management strategy of routine noninvasive functional testing to a usual-care strategy of symptom-oriented functional testing in patients with high risk clinical, anatomical, and procedural characteristics who received PCI with contemporary drug-eluting stent and bioresorbable vascular scaffold.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was > 19 years of age.
- •Subjects who underwent successful percutaneous coronary intervention with contemporary drug eluting stent, contemporary Bioresorbable Scaffold or drug eluting balloon at In-stent restenosis (ISR) lesion.
- •Patients must have at least one of the following high-risk clinical, lesion, or procedure-related risk factors.
- •Clinical factors; diabetes, renal insufficiency/failure, enzyme positive acute coronary syndrome (ACS) (STEMI or NSTEMI).
- •Lesion- or procedure-related factors ; left main lesion, bifurcation lesion, ostial lesion, chronic total occlusion lesion, multivessel disease (≥ 2 vessels stented), restenotic lesion, diffuse long lesion (lesion length ≥30 mm or stent length ≥32 mm), or vein bypass graft stented
- •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/Ethical Committee of the respective clinical site.
排除标准
- •Cardiogenic shock at the index admission
- •Subject treated with only bare metal stent or balloon angioplasty during the index procedure.
- •Pregnant and/or lactating women.
- •Concurrent medical condition with a life expectancy of less than 1 years
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •6 Subject was unable to provide written informed consent or participate in long-term follow-up.
研究组 & 干预措施
Routine stress testing at 9~15 months after PCI
Experimental
干预措施: routine stress testing (Diagnostic Test)
No Routine stress testing after PCI
Active Comparator
干预措施: No Routine stress testing (Diagnostic Test)
结局指标
主要结局
composite of major cardiovascular events
时间窗: 2 year
a composite of major cardiovascular events that included death from any cause, myocardial infarction, or hospitalization for unstable angina.
次要结局
- Death(2 year)
- Death or myocardial infarction(2 year)
- Any hospitalization(2 year)
- Myocardial infarction(2 year)
- Unstable angina hospitalization(2 year)
- Invasive catheterization(2 year)
- Repeat revascularization procedure(2 year)
研究者
Seung-Jung Park
professor
Asan Medical Center
研究点 (11)
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