Impact of IntraVascular UltraSound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,079
- 试验地点
- 2
- 主要终点
- Major adverse cardiac event, a composite of cardiac death, target lesion related MI, target lesion revascularization following randomly assigned PCI procedures with versus without IVUS guidance
研究概览
简要总结
This study is designed as a prospective, randomized, multi-center trial to demonstrate an inequality between IVUS-guided versus angiography-guided implantation of everolimus-eluting stents(EES) at long lesions(> 28 mm) in clinical outcomes at 12 months as a primary objective and safety of 6- month dual antiplatelet therapy following EES implantation in comparison with a 12-month dual antiplatelet therapy.
详细描述
The primary purpose of this study is to investigate the impact of IVUS guidance on the clinical outcomes after implantation of DES at long lesions > 28 mm.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 years old or older
- •Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia
- •Non-emergent conditions
- •Patients with signed informed consent
- •Stent length ≥28 mm by angiography estimation
- •Significant coronary artery stenosis (> 50% by visual estimate) considered for coronary revascularization with stent implantation
- •Reference vessel diameter of 2.5 to 4.0 mm by operator assessment
排除标准
- •Acute ST elevation myocardial infarction within 48 hours
- •Contraindication to anti-platelet agents & bleeding history within prior 3 months
- •Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Zotarolimus or other -limus group
- •Prior history of the following presentations
- •Cerebral vascular accident (not including transient ischemic attack)
- •Peripheral artery occlusive diseases
- •Thromboembolic disease
- •Stent thrombosis
- •Age > 80 years old
- •Severe hepatic dysfunction (3 times normal reference values)
- •Significant renal dysfunction (Serum creatinine > 2.0 mg/dl)
- •Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- •Cardiogenic shock
- •LVEF < 40%
- •Pregnant women or women with potential childbearing
- •Life expectancy < 1 year
- •Left main disease requiring PCI
- •Bifurcation lesion with 2-stent technique
- •Chronic total occlusion
- •Presence of previously implanted DES within 6-month
- •In-stent restenosis lesion
结局指标
主要结局
Major adverse cardiac event, a composite of cardiac death, target lesion related MI, target lesion revascularization following randomly assigned PCI procedures with versus without IVUS guidance
时间窗: 12 months after the index procedure
Major adverse cardiac event, a composite of cardiac death, target lesion related MI, target lesion revascularization following randomly assigned PCI procedures with versus without IVUS guidance
次要结局
未报告次要终点