Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery Disease

Fractional Flow Reserve- And Intra-vascular Ultrasound-Guided Percutaneous Coronary Intervention With Drug-Eluting Stents in Intermediate Coronary Artery Lesion (FAVOR Study)

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.

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.

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