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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Stenosis
• Intervention / Treatment: Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound); Device: Pressure wire(Radi Medical Systems)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Ilsan, Korea, Republic of
    • Inje University
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Boramae Medical Center
  • Seoul, Korea, Republic of
    • Yensei University Gangnam Severance Hospital
  • Suwon, Korea, Republic of
    • Ajou University Medical Center
  • Wonju, Korea, Republic of
    • Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravascular ultrasound	Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound); minimal lumen area on Intravascular ultrasound; Other Names: Galaxy (Boston Scientific); Virtual histology (Volcano)
Active Comparator: Fractional flow reserve	Device: Pressure wire(Radi Medical Systems); Fractional flow reserve measured by pressure wire; Other Names: Pressure wire (Radi Medical Systems)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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)
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)	2 years

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Sejung-Jea Tahk, MD, PhD, Ajou University Medical Center, Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: August 3, 2010
• First Submitted That Met QC Criteria: August 4, 2010
• First Posted (Estimate): August 5, 2010

Study Record Updates

• Last Update Posted (Estimate): February 12, 2014
• Last Update Submitted That Met QC Criteria: February 11, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: intravascular ultrasound; fractional flow reserve
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: FAVOR