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临床试验/NCT05496023
NCT05496023Unknown不适用

Pre-stenting Angiography-derived Fractional Flow Reserve Pullback Guided PercutaneouS Coronary Intervention Predicts Physiological and Clinical Outcomes in Coronary Artery Disease

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 329 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
329
试验地点
1
主要终点
Correlation of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI

研究概览

简要总结

To investigate the feasibility of physiological map generated from angiography-derived fractional flow reserve (FFR) (angio-FFR) pullback and its value in predicting physiological and clinical outcomes after stenting.

详细描述

Physiological coronary lesion evaluation such as fractional flow reserve (FFR) is now recommended by guidelines to guide percutaneous coronary intervention (PCI). However, it was not widely used in subsequent years for a variety of reasons, including the additional time needed to measure pressure wire-derived FFR, technical challenges and the small risk associated with maneuvering a pressure wire down a coronary artery, the added time to assess multiple vessels, issues with drift in the pressure wire reading, and the time, expense, and associated side effects with some hyperemic agents necessary to measure FFR.

In recent years, advancements in technology made it possible to calculate FFR from conventional coronary angiography without the need of a pressure wire or hyperemic agent. The FAVOR III (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous InterVention in Patients With cORonary Artery Disease) China has demonstrated that angiography-derived FFR (angio-FFR) improved outcomes for PCI compared with a standard angiography-guided strategy.

Like FFR, angio-FFR is also performed in a binary manner to determine whether a vessel requires intervention and does not automatically indicate the haemodynamic improvement that would be expected post stenting. However, one advantage of angio-FFR is that virtual pullback could be generated during its calculation. Most importantly, though hyperemic blood flow was applied in angio-FFR calculation, it was predicted from resting flow with mathematical algorithm. As resting flow is more constant, consistent, and predictable across different stenoses, then resting pressure changes measured along the length of a vessel will be more predictable. Using this property, a physiological vessel map could be produced with angio-FFR by co-registration the pullback onto coronary angiogram, which not only highlight functional significant lesions and lesion locations, but also offer the possibility of prospective simple computerized virtual PCI to assess the potential hemodynamic impact before actual stent implantation.

In this regard, the investigators aim to calculate angio-FFR and to develop an angio-FFR pullback. And the investigators hypothesize that angio-FFR-derived pullback would be possible to produce a physiological map showing lesion severity and location, in addition, it could be used to perform virtual PCI and predict the physiological impact of stenting; the physiological map could be used to measure physiological lesion length and intensity.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • any patient meets eligible criteria who underwent PCI with DES followed by invasive physiologic assessment at the index procedure
  • any patient who underwent PCI for lesions with pre-PCI FFR<=0.80
  • available of both pre- and post-PCI FFR measurement
  • available of both pre- and post-PCI angio-FFR calculation
  • available of pre-PCI co-registration of angio-FFR with coronary angiogram

排除标准

  • unavailable pre-PCI angio-FFR calculation and co-registration with coronary angiogram
  • unavailable post-PCI angio-FFR calculation
  • culprit vessel of acute coronary syndrome
  • failed achieving TIMI 3 flow at the end of PCI
  • left ventricular ejection fraction <30%
  • graft vessel
  • collateral feeder
  • in-stent restenosis
  • primary myocardial or valvular heart disease
  • in patient whose life expectancy less than 2 years
  • visible thrombus of target vessel segment

结局指标

主要结局

Correlation of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI

时间窗: Immediate post-PCI

Pearson Correlation analysis will be performed to assess the correlation of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI

Agreement of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI

时间窗: Immediate post-PCI

Bland-altman analysis will be performed to assess the agreement of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI

Propotion of angio-FFR based physiological map successfully created

时间窗: Immediate after angiography

Propotion of successful angio-FFR based physiological map created by overlaying the angio-FFR based pullback onto coronary angiogram will be calculated

次要结局

  • Correlation of pre-PCI angio-FFR derived pullback pressure gradient with post-PCI FFR(Immediate post-PCI)
  • Agreement of pre-PCI angio-FFR with pre-PCI FFR(Immediate after pre-PCI FFR measurement)
  • Correlation of post-PCI angio-FFR with post-PCI FFR(Immediate post-PCI FFR measurement)
  • Target Vessel Failure(2 years after index procedure)
  • Correlation of pre-PCI angio-FFR with pre-PCI FFR(Immediate after pre-PCI FFR measurement)
  • Agreement of post-PCI angio-FFR with post-PCI FFR(Immediate post-PCI FFR measurement)
  • Correlation of pre-PCI angio-FFR derived pullback pressure gradient (PPG) with post-PCI angio-FFR(Immediate post-PCI)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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