Coronary Artery Stenosis
Conditions
Keywords
intravascular ultrasound, fractional flow reserve
Brief summary
This study is a prospective, randomized, multi-center, open label trial to compare the clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional Flow Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate coronary artery lesion.
Detailed description
This trial is a prospective, randomized, open label, two arm designed multi-center trial. When diagnostic coronary angiogram shows that the target lesion is intermediate stenosis, IVUS and/or FFR will be performed in order to decide PCI or defer by 1:1 randomization. The patients would be followed up to 2 years clinically.
Interventions
DEVICEGrey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)
minimal lumen area on Intravascular ultrasound
DEVICEPressure wire(Radi Medical Systems)
Fractional flow reserve measured by pressure wire
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Clinical indication: * Patients with angina or patients with documented silent ischemia * Patients who are eligible for intracoronary stenting * Age \> 18 years old, \< 75 years old Angiographic indication: * Intermediate coronary artery disease (30-70% diameter stenosis) by visual estimation * Reference vessel diameter ≥ 3.0mm by visual estimation
Exclusion criteria
* Acute or old myocardial infarction * Previous coronary artery bypass graft * Left main disease (≥ 50% stenosis) * In-stent restenosis lesion * Chronic total occlusion * Low ejection fraction (\< 40 %) * Graft vessel lesion * History of bleeding diathesis or coagulopathy * Limited life-expectancy (less than 1 year) due to combined serious disease * Contra-indication to heparin, everolimus * Contraindication to aspirin, clopidogrel or cilostazol * Pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial infarction (MI) | 1 and 2 years |
| Composite of cardiac death or myocardial infarction | 1 and 2 years |
| Target vessel revascularization (ischemia- and clinically-driven) | 1 and 2 years |
| Target lesion revascularization (ischemia- and clinically-driven) | 1 and 2 years |
| Stent thrombosis (Academic Research Consortium criteria) | 1 and 2 years |
| In-stent and in-segment late loss on angiographic follow-up | 1 year |
| Cardiac death | 1 and 2 years |
| Incidence and angiographic pattern of restenosis | 1 year |
| Canadian Cardiovascular Society Classification status | 1 and 2 years |
| The number of anti-angina medication | 1 and 2 years |
| Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group | Baseline (day 0) |
| Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) | 2 years |
| In-stent and in-segment restenosis rate | 1 year |
Countries
South Korea
Outcome results
None listed