Arterial Occlusive Diseases, Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Heart Diseases, Myocardial Ischemia, Vascular Diseases
Conditions
Keywords
Fractional Flow Reserve, Quantitative Coronary Angiography, Coronary artery disease, Quantitative Flow Ratio, Tandem lesion, Virtual stenting
Brief summary
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.
Detailed description
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.
Interventions
DEVICEQuantitative Flow Ratio (QFR)
FFR measured by pressure wire, QFR computed by coronary angiographic images
Sponsors
Shanghai Chest Hospital
Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General inclusion Criteria: 1. Stable and unstable angina pectoris or secondary evaluation of stenosis after acute MI; 2. Age \> 18 years; 3. Able to provide signed informed consent. * Angiographic inclusion criteria: 1. At least two localized lesions on the same coronary artery; 2. More than 50% diameter stenosis (DS) estimated by QCA on each lesion; 3. At least 10 mm relatively normal lumen (at most 20% DS) between two lesions; 4. Reference vessel size \> 2 mm in stenotic segment by visual estimate.
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of QFR in tandem lesions as compared with FFR prior to intervention | 1 hour | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of QFR-based virtual stenting in predicting FFR values after revascularizing the culprit lesion | 1 hour | 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) |
Countries
China
Outcome results
None listed