Coronary Disease
Conditions
Keywords
fractional flow reserve, drug eluting stent, coronary atherosclerosis
Brief summary
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
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.
Interventions
None listed
Sponsors
Seoul National University Hospital
Keimyung University Dongsan Medical Center
Ulsan University Hospital
Busan Veterans General Hospital
Samsung Medical Center
Sejong General Hospital
Tokyo Medical University
Gifu Heart Center
Japanese Red Cross Kyoto Daini Hospital
Inje University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target-vessel failure | 2 years after index procedure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical, angiographic and physiologic predictors for target-vessel failure | 2 years after index procedure | Clinical, angiographic and physiologic predictors for target-vessel failure by univariate and multivariate analysis will be performed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Intravascular ultrasound (IVUS) derived predictors for post-stent FFR and target vessel failure | 2 years after index procedure | In patient who performed IVUS examination, IVUS derived parameters will be evaluated for the prediction of post-stent FFR and target-vessel failure |
Countries
South Korea
Outcome results
None listed