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Even in the era of drug-eluting stents, bifurcation lesions remain one of the most challenging lesion subsets in coronary intervention practice. This study was performed to evaluate the functional outcomes of pressure wires (IFR)-guided jailed side-branch intervention strategy.
Fractional flow reserve (FFR) measurements require minimal and constant microvascular resistance which is routinely achieved by intravenous adenosine infusion. Adenosine-induced hyperemia establishes an optimal vascular environment for FFR measurement. However, breathlessness and chest tightness are common adverse events during adenosine infusion and severe asthma occurs occasionally. The Introduction of an adenosine-independent index (instantaneous wave-free ratio [iFR]) into clinical practice offered easier and hyperemia-free method for lesion assessment.
Physiological changes and clinical evaluation of iFR warrants further research. Therefore, the investigators conducted this study to evaluate the functional aspects of iFR-guided provisional jailed side-branch intervention strategy and compare clinical endpoints to conventional non-iFR-guided operations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iFR pressure-wire | Experimental |
| |
| Conventional | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iFR pressure-wire | Device | The instantaneous wave-free ratio (iFR) as an adenosine-independent index of coronary stenosis severity, calculated as the ratio between the distal trans-stenotic pressure and the proximal coronary pressure during a specific diastolic wave-free period |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological evaluation of iFR-guided intervention | iFR changes after drug-eluting balloon (DEB) inflation of the jailed side branch. | 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| length of hospital stay | 6-month | |
| Procedure time | 30-day | |
| Fluoroscopy time |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Conventional | Device | Other diagnostic devices (including FFR and angiography) |
|
| 30-day |
| In-hospital heart failure class | 30-day |
| 6-month heart failure class | 6-month |
| Post-PCI angina | Comparison of the incidence of angina after performing PCI in both the iFR and conventional groups | 6-month |
| Ejection fraction at 6 months' post operation | 6-month |
| The amount of dye injection for angiography | 30-day |