Clinical trial NCT01175863: Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery Disease
Official title: Fractional Flow Reserve- And Intra-vascular Ultrasound-Guided Percutaneous Coronary Intervention With Drug-Eluting Stents in Intermediate Coronary Artery Lesion (FAVOR Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Stenosis
Keywords: intravascular ultrasound
fractional flow reserve
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2010-08-05
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Contraindication to aspirin, clopidogrel or cilostazol
* Pregnant

Primary outcomes:
measure: Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
timeFrame: 1 year
Secondary outcomes:
measure: Cardiac death
timeFrame: 1 and 2 years
measure: Myocardial infarction (MI)
timeFrame: 1 and 2 years
measure: Composite of cardiac death or myocardial infarction
timeFrame: 1 and 2 years
measure: Target vessel revascularization (ischemia- and clinically-driven)
timeFrame: 1 and 2 years
measure: Target lesion revascularization (ischemia- and clinically-driven)
timeFrame: 1 and 2 years
measure: Stent thrombosis (Academic Research Consortium criteria)
timeFrame: 1 and 2 years
measure: In-stent and in-segment late loss on angiographic follow-up
timeFrame: 1 year
measure: In-stent and in-segment restenosis rate
timeFrame: 1 year
measure: Incidence and angiographic pattern of restenosis
timeFrame: 1 year
measure: Canadian Cardiovascular Society Classification status
timeFrame: 1 and 2 years
measure: The number of anti-angina medication
timeFrame: 1 and 2 years
measure: Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group
timeFrame: Baseline (day 0)
measure: Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
timeFrame: 2 years
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung university Dongsan medical center
city: Ilsan
country: Korea, Republic of
facility: Inje University
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
city: Seoul
country: Korea, Republic of
facility: Yensei University Gangnam Severance Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
city: Wonju
country: Korea, Republic of
facility: Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital
Study officials:
affiliation: Ajou University Medical Center, Ajou University School of Medicine
name: Sejung-Jea Tahk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: