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

Ajou University School of Medicine

Status and phase: Terminated; Phase 4

Conditions: Coronary Artery Stenosis

Treatments: Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound); Device: Pressure wire(Radi Medical Systems)

Study type: Interventional

Funder types: Other

Identifiers

NCT01175863

FAVOR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,400 participants in 2 patient groups

Intravascular ultrasound

Active Comparator group

Treatment:

Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)

Fractional flow reserve

Active Comparator group

Treatment:

Device: Pressure wire(Radi Medical Systems)