OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation Compared to Angiography: a Multicenter Randomized TriaL in PCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,487
- 试验地点
- 159
- 主要终点
- Imaging Outcome (Powered): Minimal Stent Area (MSA)
研究概览
简要总结
The objective of this prospective, single-blind clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.
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
- Double (Participant, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Imaging Outcome (Powered): Minimal Stent Area (MSA)
时间窗: Final Post-PCI Measurement (average of 24 hours).
Minimal Stent Area (per target lesion basis) assessed by OCT in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment.
Number of Participants With Target Vessel Failure (TVF)
时间窗: At 2 years
Time-to-first event rate of the composite outcome of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR), will be assessed.
次要结局
- Number of Participants With Target Vessel Failure (TVF) Excluding Periprocedural MI (Powered)(At 2 years)
- The Number of Participants With Stent Thrombosis(2 years)
- The Results of Adjudicated Clinical Outcomes to 2 Years in the Randomized Population(2 years)