An observational study in Coronary Artery Disease, Cardiovascular Diseases and Myocardial Ischemia, sponsored by Pulse Medical Imaging Technology (Shanghai) Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by Pulse Medical Imaging Technology (Shanghai) Co., Ltd · Observational
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Virtual stent implantation technique combined with QFR was recently developed to predict the functional significance of coronary stenosis as if the stenosis was revascularized.
The purpose of this study is to evaluate the diagnostic accuracy of QFR in in tandem lesions with fractional flow reserve (FFR) as the reference standard. The secondary purpose is to evaluate the diagnostic accuracy of QFR-based virtual stent technique in predicting the FFR values after revascularizing the culprit lesion.
QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel. 3D coronary models can be reconstructed based on two angiographic projections to obtain the geometric parameters, including vascular diameter or cross-sectional area. According to the lesion stenosis, vessel curvature, conical geometry and reference lumen characteristics, pressure drop can be calculated in real time based on its relationship with blood flow. There is no need for pressure wire and adenosine / ATP induced maximum hyperemia compared with FFR.
The FAVOR Pilot Study and FAVOR II China Study showed promising results for diagnostic accuracy in consecutive patients. However, the diagnostic accuracy of QFR in specific tandem lesions needs further investigation. Furthermore, using the virtual stent technology to accurately assess the culprit lesion and choose the optimal treatment is significant in precisely guiding PCI surgery.
Patients with coronary tandem lesions admitted for coronary angiography due to high risk of significant coronary stenosis
General inclusion Criteria:
Angiographic inclusion criteria:
Exclusion Criteria:
General exclusion criteria:
Serious complications:
Angiographic exclusion criteria:
FFR measured by pressure wire, QFR computed by coronary angiographic images
Diagnostic accuracy of QFR in tandem lesions as compared with FFR prior to intervention
Diagnostic accuracy was defined as the concordance ratio of QFR evaluated outcomes (≤ 0.8 or \> 0.8) with the reference standard FFR evaluated outcomes (≤ 0.8 or \> 0.8)
Time frame: 1 hour
Diagnostic accuracy of QFR-based virtual stenting in predicting FFR values after revascularizing the culprit lesion
Diagnostic accuracy was defined as the concordance ratio of QFR evaluated outcomes (≤ 0.8 or \> 0.8) with the reference standard FFR evaluated outcomes (≤ 0.8 or \> 0.8)
Time frame: 1 hour
Plan to share: No
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Pulse Medical Imaging Technology (Shanghai) Co., Ltd