Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With St-segment Elevation Myocardial Infarction (Copernican)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,272
- 试验地点
- 36
- 主要终点
- Target lesion failure (TLF)
研究概览
简要总结
The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI).
Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies:
- Study group: reduced stent PCI strategy (DCB-based)
- Control group: conventional PCI strategy (DES-based).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 presenting with STEMI and indication to undergo pPCI.
排除标准
- •Life expectancy <1 year due 1 to non-cardiac disease.
- •Inability to provide informed consent.
- •Cardiogenic shock.
- •Left ventricular ejection fraction <15%.
- •Left main disease.
- •Stent thrombosis
- •Patients with prior bypass graft lesions requiring PCI (culprit or non culprit lesions).
- •Patients with chronic total occlusions.
- •Untreatable coronary disease.
- •Non-identified culprit lesion.
- •Known allergy to aspirin, ticagrelor, prasugrel, clopidogrel, paclitaxel or sirolimus.
研究组 & 干预措施
DCB-based
Reduced stent PCI strategy: Culprit lesion revascularization with DCB will be performed after coronary predilation if residual stenosis ≤30%, lack of dissections >type B and TIMI 3 flow. If the aforementioned culprit-lesion characteristics are not achieved after DCB-PCI, a DES will be implanted.
干预措施: Primary PCI (Device)
DES-based
Control group
结局指标
主要结局
Target lesion failure (TLF)
时间窗: 12 months
Target-vessel myocardial infarction or ischemia-driven target-lesion revascularization
次要结局
- Incidence of bleeding(10 years)
- Incidence of myocardial infarction(10 years)
- Incidence of target lesion revascularization(10 years)
- Incidence of stent thrombosis(10 years)
- Incidence of acute vessel closure(10 years)
- Incidence of cardiovascular death(10 years)
- Incidence of all-cause death(10 years)
- Incidence of stroke(10 years)
- Incidence of acute kidney injury(10 years)
研究者
Jorge Sanz Sanchez
Principal Investigator
Hospital Universitario La Fe