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

Ajou University School of Medicine8 sites in 1 country1,400 target enrollmentFebruary 2010

ConditionsCoronary Artery Stenosis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Coronary Artery Stenosis
Sponsor: Ajou University School of Medicine
Enrollment: 1400
Locations: 8
Primary Endpoint: Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

May 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ajou University School of Medicine

Responsible Party

Principal Investigator

Seung-Jea Tahk

Ajou University School of Medicine

Eligibility Criteria

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

Outcomes

Primary Outcomes

Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)

Time Frame: 1 year

Secondary Outcomes

Stent thrombosis (Academic Research Consortium criteria)(1 and 2 years)
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)
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)