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Murray-law based single-view quantitative flow ratio (µQFR) has been recommended for guiding percutaneous coronary intervention (PCI) in selective patients. However, it's reliability has not been validated in bifurcation lesions which present complex anatomy and flluid conditions before and after PCI. The goal of this study is to investigate the diagnostic performance of µQFR in side branch after single-stent treatment for bifurcation lesions in patient with obstructive coronary artery diseases.
The Murray law-based quantitative flow ratio (µQFR), derived from single-view angiography, is an established computational method for non-invasive functional assessment of coronary stenoses. Its utility in guiding percutaneous coronary intervention (PCI) in selected patients with straightforward lesions is recognized. However, its diagnostic reliability remains unvalidated in the context of coronary bifurcation lesions. These lesions exhibit inherent geometric and hemodynamic complexity due to altered flow patterns and shear stress distribution, both pre- and post-intervention. This complexity is particularly pertinent to side branches following single-stent strategies. Significant alterations in the local hemodynamic environment occur after stent deployment in the main vessel, potentially impacting side branch physiology and the accuracy of µQFR calculations specifically within this branch. Consequently, an evidence gap persists regarding the performance of µQFR for functional evaluation of the side branch after bifurcation PCI. This study specifically aims to evaluate the diagnostic performance of µQFR for assessing the functional significance of side branch stenoses after single-stent treatment of bifurcation lesions in patients with obstructive coronary artery disease (CAD). The primary objective is to determine the diagnostic performance of post-procedural µQFR measurements within the side branch of such complex lesions. The second objective is to investigate potential factors influencing the diagnostic performance of µQFR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main stent before branch balloon | Patiens is allocated pot-hoc to this group if the operator performs the single stent in the main branch first and follows with balloon expansion in the ostium of the side branch. Angiography will be saved anonymously and sent to an independent core lab for µQFR calculation. Operaters are blinded to µQFR results. µQFR measurement will be repeated before and after intervention in both main and side branches. | ||
| Main stent after branch balloon | Patiens is allocated pot-hoc to this group if the operator performs expend the ostium of the side branch and then plants the single stent in the main branch. Angiography will be saved anonymously and sent to an independent core lab for µQFR calculation. Operaters are blinded to µQFR results. µQFR measurement will be repeated before and after intervention in both main and side branches. |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of µQFR in side branch | The diagnostic accuracy of µQFR in assessing ischemia in the side branch, using FFR as the gold standard, following main vessel stenting. | Perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of µQFR in main branch | The effect of intravascular ultrasound (IVUS)-derived parameters on the diagnostic performance of µQFR in assessing ischemia in the main branch before and after stenting, using FFR as the gold standard. | Perioperative |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with obstructive bifurcation lesions who intended to undergo single-stent treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenguang Li, MD, PhD | Contact | 008664041990 | li.chenguang@zs-hospital.sh.cn | |
| Jinying Zhou, MD, PhD | Contact | zhou.jinying@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
IPD sharing might be possible upon reasonable requirement and under institutional administrative regulations.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |