LEft Main Oct Guided iNterventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 22
- 主要终点
- success of the OCT procedure
研究概览
简要总结
LEMON aim is to evaluate the feasibility, efficiency and security of a standardized Optical Coherence Tomography (OCT) - guided protocol for completion and optimization of Left Main (LM) Percutaneous Coronary Intervention (PCI).
详细描述
The LEMON study (LEft Main Oct-guided iNterventions) is a prospective, multicentre, open-label, interventional , non-randomized trial that investigates the feasibility and efficiency of OCT guidance for left main PCI in 10 active French interventional cardiology centres. The aim of the study is the appliance of a pre-defined standardized protocol for LM PCI . The LM PCI strategy is guided by 3 OCT runs, according to a pre-determined protocol. The first OCT run (run1) is performed before any stent implantation, the second run (run2) is performed after the stent is implanted, POT (proximal optimization technique) is applied and side branch iss rewired through stent struts. The third run (run3) is performed after PCI optimization. In case of additional stent optimization, a supplementary OCT run is applied in order to assess final result.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •stable or non-stable distal Left Main lesion (with or without previous Coronary Artery Bypass Graft), involving or not Left Anterior Descending and Coronary Circumflex ostias and requiring Percutaneous Coronary Intervention with a one or two stents strategy
- •stable or non-stable ostial Left Anterior Descending and/or Coronary Circumflex lesion requiring Percutaneous Coronary Intervention with involvement of distal Left Main
- •SYNTAX angiographic score <23
- •informed consent
排除标准
- •ostial Left Main lesion
- •on-going acute STEMI
- •on-going cardiogenic shock
- •severe chronic renal failure (Cr Cl <30 ml/min/m2)
- •anticipated technical contra-indication to OCT (highly calcified lesions, severe proximal tortuosity)
结局指标
主要结局
success of the OCT procedure
时间窗: Post PCI / Immediate
score Thrombolysis In Myocardial Infarction (TIMI) equal to 3 in all vessels, 50% residual stenosis in the various angiography segments, adequate expansion according to minimum intra stent area \> 80% of the luminal area of the reference segment on Main Vessel and Main Branch.
次要结局
- incidence of major adverse cardiovascular events(30 days post PCI)
- rate of appropriate wire position(30 days post PCI)
- rate of appropriate stent expansion according to DOCTORS and ILUMIEN-III criteria.(30 days post PCI)