NCT01175863

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)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,400 (estimated)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)	minimal lumen area on Intravascular ultrasound
DEVICE	Pressure wire(Radi Medical Systems)	Fractional flow reserve measured by pressure wire

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-08-05
• Last updated: 2014-02-12

Locations

8 sites across 1 country: South Korea