Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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Fractional flow reserve (FFR) is a physiologic index for the determination of ischemia-causing coronary stenosis as well as drug eluting stent (DES) optimization, even multiple anatomic imaging parameters have been widely used in clinical practice for the assessment of optimal stent procedure. Prognostic value of post-stent FFR (FFRpost) have been rarely evaluated in patient treated with 2nd generation DES. This multicentre, prospective registry was aimed to evaluate the influence of physiologic parameters on the clinical outcome after 2nd generation DES implantation.

Detailed Description
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Patients who diagnosed obstructive coronary artery disease and treated by DES with FFR examination would be enrolled, consecutively. FFR measurement would be required at the baseline and at the end of index PCI procedure. PCI procedure would be performed upon local routine. Any available 2nd generation DES could be used. Informed consent should be obtained and protocol should be approved by each collaborator's institutional review board (IRB). Web-based electronic-case record form (CRF) system will be used for collecting data. All data will be handled and analyzed by blind fashion at independent core lab. Patient will be followed-up at each collaborator's hospital at least 2 year after index procedure. Any adverse event will be reported and addressed immediately by appropriate medical treatment to protect patient.

Official Title
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Influence of Fractional Flow Reserve (FFR) on the Clinical OutcomEs of PERcutaneouS Coronary Intervention (PCI): A ProspECTIVE, Multicenter FFR Registry

Conditions
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Coronary Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: any patient meets eligible criteria who underwent PCI with DES followed by FFR measurement at the index procedure patient who provide informed consent Exclusion Criteria: culprit vessel of acute coronary syndrome failed achieving TIMI 3 flow at the end of PCI left ventricular ejection fraction <30% graft vessel collateral feeder in-stent stenosis primary myocardial or valvular heart disease in patient whose life expectancy less than 2 years visible thrombus of target vessel segment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FFRpost<br>High FFRpost group and low FFRpost group were defined according to the optimal cut-off value for predicting clinical outcome. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target-vessel failure | During two-year follow-up period, target-vessel failure (composite of cardiac death, target-vessel related myocardial infarction, and clinically-driven target vessel revascularization) will be evaluated. Target vessel will be defined as the treated vessel with DES which assessed by post-stent FFR. All clinical outcome will be reported according to the location of target vessel (LAD vs. non-LAD). | 2 years after index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical, angiographic and physiologic predictors for target-vessel failure | Clinical, angiographic and physiologic predictors for target-vessel failure by univariate and multivariate analysis will be performed. | 2 years after index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fractional flow reserve, drug eluting stent, coronary atherosclerosis