The Implementation of Intravascular Ultrasound and Fractional Flow Reserve in the Percutaneous Treatment of Very Long Coronary Artery Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The proportion of patients with optimal anatomy result
研究概览
简要总结
A single center, prospective, observational study to investigate the impact of intravascular ultrasound (IVUS) on the functional percutaneous coronary intervention (PCI) result (assessed with fractional flow reserve (FFR)) and one-year target vessel failure (TVF) rate after percutaneous treatment of long coronary artery lesions
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Chronic coronary syndrome (stable angina; staged PCI to other lesions after acute myocardial infarction with ST segment elevation);
- •Acute coronary syndrome without ST segment elevation (unstable angina or myocardial infarction without ST segment elevation);
- •Functionally significant (FFR ≤ 0.8) lesion requiring a stent length of ≥ 30 mm and amenable for percutaneous coronary intervention.
排除标准
- •Patient's age ≤ 18 years;
- •Acute myocardial infarction with ST segment elevation;
- •Treatment with dual antiplatelet therapy contraindicated;
- •Survival expectancy ≤ 1 year;
- •Known allergy to sirolimus, everolimus or zotarolimus.
结局指标
主要结局
The proportion of patients with optimal anatomy result
时间窗: 1 day
If all the four following IVUS criteria met: (1) good stent apposition; (2) good stent expansion (minimal stent area (MSA) \>90% of distal reference lumen area and/or MSA ≥5.5mm2); (3) plaque burden 5mm proximal and distal to the stent \<50%); (4) no stent edge dissection.
The proportion of patients with optimal physiology result
时间窗: 1 day
Post PCI FFR value ≥ 0.9
The proportion of patients with optimal physiology and anatomy result
时间窗: 1 day
Post PCI FFR value ≥ 0.9 and all four IVUS criteria met
次要结局
- The rate of target vessel failure (TVF)(12 months post PCI follow up)
研究者
Povilas Budrys
Principal investigator
Vilnius University Hospital Santaros Klinikos