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| Name | Class |
|---|---|
| Shanghai Chest Hospital | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantitative Flow Ratio (QFR) | Device | FFR measured by pressure wire, QFR computed by coronary angiographic images |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 hour |
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Inclusion Criteria:
General inclusion Criteria:
Angiographic inclusion criteria:
Exclusion Criteria:
General exclusion criteria:
Ineligible for diagnostic intervention or FFR examination;
Myocardial infarction within 72 hours;
Severe heart failure (NYHA≥III);
S-creatinine>150µmol/L or GFR<45 ml/kg/1.73m2;
Allergy to contrast agent or adenosine;
Factors that might substantially impact the angiographic image quality, e.g, frequent atrial premature beat or atrial fibrillation;
Serious complications:
Cardiogenic shock or circulation capacity failure;
Two-degree and more severe atrioventricular block, with no permanent pacemaker implanted;
Pregnancy or lactation;
The investigators believe that the treatment regimen may be detrimental to the patient or the enrollment of this subject may affect the specific assessment of the trial;
Angiographic exclusion criteria:
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Patients with coronary tandem lesions admitted for coronary angiography due to high risk of significant coronary stenosis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huadong Hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27712739 | Background | Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D001157 | Arterial Occlusive Diseases |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
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