A Randomized Trial of the Treatment of Non- Culprit Lesion After STEMI: Bioresorbable Vascular Scaffold Versus Optimal Medical Therapy (NCLstudy)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- measure size of the vulnerable plaque
研究概览
简要总结
The aim of the present study is to compare the evolution of non culprit lesions after treatment by BVS versus optimal medical therapy at 2-years follow- up
详细描述
Objectives and hypothesis: scaffolding a non culprit /vulnerable coronary plaque with BVS could facilitate the stabilization process into the atherosclerotic plaque with modifications of plaque morphology, especially the lipid content which is considered as one of the main factor leading to recurrent MACE after an ACS.
The interaction between the polymer Platform and the vessel wall, the effect of the everolimus on neointima growth and cellular response into the media could reduce the inflammatory process into the vulnerable plaque could be different Under OMT and BVS implantation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI and multivessel ASCL
- •Successful and uneventful primary PCI
- •Non culprit lesion > /= 2.5mm RVD suitable for investigation by FFR
- •At least one segment of minimum 10 mm length containing a non culprit lesion
排除标准
- •non compliant profile
- •patient not able to sign an IC
- •cardiogenic shock
- •left main disease
- •GFR<30ml/min/m2
- •previous CABG
- •LVEF<35%
研究组 & 干预措施
OMT
Comparator with ONLY optimal medical treatment (OMT): the aim of the study is to compare the evolution of non culprit lesions after treatment by BVS versus Optimal Medical Therapy at 2 years follow- up.
Intervention: medical treatment
干预措施: O.M.T (Drug)
结局指标
主要结局
measure size of the vulnerable plaque
时间窗: 2 years
the size of the vulnerable plaque measured by angio FU at 2 years with an investigation of the same segment than at baseline.
次要结局
未报告次要终点