Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention

Inje University1,250 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,250

Conditions

Coronary Disease

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (4)

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Seoul National University Hospital

Seoul, South Korea

Ulsan University Hospital

Ulsan, South Korea

Outcomes

Primary Outcomes

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).

Time frame: 2 years after index procedure

Secondary Outcomes

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.

Time frame: 2 years after index procedure

Data from ClinicalTrials.gov

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