iFR Pressure Wires in Assessment of the Provisional Side-branch Intervention Strategy for Bifurcation Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Physiological and Clinical Assessment of the Provisional Side-branch Intervention Strategy for Coronary Bifurcation Lesions Using iFR Pressure Wires

Conditions
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Coronary Bifurcation Lesions

Intervention / Treatment
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* Device: iFR pressure-wire
* Device: Conventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute coronary syndrome Jailed side-branch of a vessel size > 2 mm Vessel length > 40 mm Lesion length < 10 mm by visual estimation Exclusion Criteria: Significant stenosis in the left main coronary artery or the main branch proximal to the stented segment Totally occluded bifurcation lesions Primary myocardial disease Serum creatinine level of ≥ 2.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iFR pressure-wire<br> | Device: iFR pressure-wire<br>* 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<br>|
| Active Comparator: Conventional<br> | Device: Conventional<br>* Other diagnostic devices (including FFR and angiography)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay |  | 6-month | 
| Procedure time |  | 30-day | 
| Fluoroscopy time |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Provisional side-branch intervention strategy, iFR, Pilot study