A Prospective, Global, Multicenter, Non-Randomized, Non-Blinded Study in Patients With Intermediate Coronary Lesions to Examine the Correlation Between Fractional Flow Reserve (FFR) and Intravascular Ultrasound With Virtual Histology (VH-IVUS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 主要终点
- The concordance between FFR and IVUS minimum lumen area(MLA) as assessed by continuous correlation (regression), categorical cutoff values , and being unadjusted and adjusted for lesion length, %plaque burden(PB) and VH-thin capped Fibro Atheroma(TCFA)
研究概览
简要总结
The present prospective, multicenter study will therefore be performed with the primary objective of establishing the correlation between fractional flow reserve (FFR) and intravascular ultrasound with virtual histology (VH-IVUS)-derived parameters in angiographically intermediate coronary lesions. The current study will also examine the relative prognostic utility of FFR and VH-IVUS as a tool to defer percutaneous coronary intervention (PCI), by assessing the long-term rate (up to 3 years) of lesion-related clinical events if deferred by FFR vs. VH-IVUS versus not deferred PCI.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The concordance between FFR and IVUS minimum lumen area(MLA) as assessed by continuous correlation (regression), categorical cutoff values , and being unadjusted and adjusted for lesion length, %plaque burden(PB) and VH-thin capped Fibro Atheroma(TCFA)
时间窗: 3 year
次要结局
- The concordance between operator assessed % diameter stenosis(DS), core lab assessed %DS, FFR and MLA in intermediate lesions(3 year)
- Operator assessed and core lab assessed angiographic %DS, and VH-IVUS MLA, lesion length, %PB, and plaque types in intermediate lesions, with core lab assessment as the reference(3 year)
- FFR and VH-IVUS derived MLA, %PB, lesion length, and plaque type in deferred vs. treated lesions(3 year)
- Operator revascularization decisions (deferral vs. PCI/coronary artery bypass graft(CABG)) according to operator assessed angiographic %DS, FFR and VH-IVUS results in intermediate coronary lesions(3 year)
- Deferred study lesion clinical event rates up to three years according to %DS, FFR and VH-IVUS, and comparison with treated study lesion clinical event rates up to three years(3 year)
- Treated study lesion clinical event rates up to three years and their correlation with index FFR and VH-IVUS pre and post stenting(3 year)