仅供临床科研使用
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销售价格: N/A
商品编号: AS-0249-1774
软件语言: 英文
器械分类: II
生产厂家: Pie Medical Imaging B.V.
公司网址: https://www.piemedicalimaging.com/
认证信息: FDA
系统要求: Windows
交付方式: 下载安装
  • 软件概览
  • 推荐配置
  • 典型病例
  • 软件教程
  • 临床文献
  • 用户评价
  • 产品彩页

软件概览

vFFR

The novel angio-based functional lesion assessment: wire and adenosine free

The vFFR workflow builds a 3D reconstruction of coronary artery and assesses pressuredrop, resulting in a vFFR value. Furthermore, with the 3D reconstruction anatomicalesion information is provided, like the percentage stenosis.

Functional lesion information

Pressure drops in coronary artery

vFFR value

Anatomical lesion information

Lesion diameter

Percentage stenosis

Reference diameter

Obstruction lenath

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Click to watch the video

*The residual vFFR functionality does not have FDA clearance and can therefore NOT be used in the USA

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推荐配置


典型病例

Clinical Evidence

vFFR is subject of two multi-center randomized clinical trials investigating the effectiveness of vFFR guided revascularization vs FFR guided revascularization in over 4000 patients:The FASTIII trial is led by Dr. Joost Daemen (Erasmus Medical Center, Rotterdam, The Netherlands) , investigator initiated and sponsored by the European Cardiovascular Research Institute (ECRI). All study details can be found here: https://www.ecri-trials.com/studies/fast-iii/

The LIPSIA STRATEGY trial is led by Prof. Holger Thiele (Herzzentrum Leipzig) and investigator initiated. More information can be found here: https://www.clinicaltrials.gov/ct2/show/NCT03497637   

vFFR is and has been subject to multiple single and multi-center trials investigating diagnostic accuracy to predict FFR ≤ 0.8, accuracy in post-PCI setting and accuracy related to IVUS, OCT, NHPR. A full overview can be found here.


软件教程


临床文献

key publications

Masdjedi K, Van Zandvoort L, Balbi M, Gijsen F, Ligthart J, Rutten M, Lemmert M, Wildschut J, Diletti R, Zijlstra F, Van Mieghem N, Daemen J. Validation of 3-Dimensional Quantitative Coronary Angiography based software to calculate Fractional Flow Reserve: Fast Assessment of STenosis severity (FAST)-study. EuroIntervention 2019; Jaa-580 2019, doi: 10.4244/EIJ-D-19-00466

Masdjedi K, Tanaka N, Van Belle E, Porouchani S, Linke A, Woitek F, Bartorelli A, Ali Z, den Dekker W, Wilschut J, Diletti R, Zijlstra F, Boersma E, Van Mieghem M, Spitzer E, Daemen J.  Vessel Fractional Flow Reserve (vFFR) for the assessment of stenosis severity: the FAST II study. EuroIntervention 2021; 17, doi: 10.4244/EIJ-D-21-00471 .

Neleman T, Masdjedi K, Van Zandvoort LJC, Tomaniak M, Ligthart JMR, Witberg KT, Vermaire AA, Boersma E, Van Mieghem NM, Daemen J. Extended Validation of Novel 3D Quantitative Coronary Angiography-Based Software to Calculate vFFR: The FAST EXTEND Study. JACC Cardiovasc Imaging. 2021 Feb;14(2):504-506. doi: 10.1016/j.jcmg.2020.08.006. Epub 2020 Sep 30. PMID: 33011122.

Masdjedi, K, van Zandvoort, LJ, Balbi, MM, et al. Validation of novel 3‐dimensional quantitative coronary angiography based software to calculate fractional flow reserve post stenting. Catheter Cardiovasc Interv. 2020; 1– 7. https://doi.org/10.1002/ccd.29311

Tomaniak, M, Masdjedi, K, van Zandvoort, LJ, et al. Correlation between 3D‐QCA based FFR and quantitative lumen assessment by IVUS for left main coronary artery stenoses. Catheter Cardiovasc Interv. 2020; 1– 7. https://doi.org/10.1002/ccd.29151


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