Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery Disease
- Conditions
- Coronary Artery Stenosis
- Interventions
- Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)Device: Pressure wire(Radi Medical Systems)
- Registration Number
- NCT01175863
- Lead Sponsor
- Ajou University School of Medicine
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1400
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravascular ultrasound Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound) - Fractional flow reserve Pressure wire(Radi Medical Systems) -
- Primary Outcome Measures
Name Time Method Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) 1 year
- Secondary Outcome Measures
Name Time Method Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) 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) Cardiac death 1 and 2 years 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 In-stent and in-segment restenosis rate 1 year Incidence and angiographic pattern of restenosis 1 year Canadian Cardiovascular Society Classification status 1 and 2 years
Trial Locations
- Locations (8)
Inje University
🇰🇷Ilsan, Korea, Republic of
Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Keimyung university Dongsan medical center
🇰🇷Daegu, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Yensei University Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital
🇰🇷Wonju, Korea, Republic of
Seoul national university hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Medical Center
🇰🇷Suwon, Korea, Republic of