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

Coronary Artery Stenosis Clinical Trial

— FAVOR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01175863
• Other study ID #: FAVOR
• Status: Terminated
• Phase: Phase 4
• First received: August 3, 2010
• Last updated: February 11, 2014
• Start date: February 2010
• Est. completion date: May 2014

Study information

• Verified date: February 2014
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1400
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Keimyung university Dongsan medical center	Daegu
Korea, Republic of	Inje University	Ilsan
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul national university hospital	Seoul
Korea, Republic of	Yensei University Gangnam Severance Hospital	Seoul
Korea, Republic of	Ajou University Medical Center	Suwon
Korea, Republic of	Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital	Wonju

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)		1 year	Yes
Secondary	Cardiac death		1 and 2 years	Yes
Secondary	Myocardial infarction (MI)		1 and 2 years	Yes
Secondary	Composite of cardiac death or myocardial infarction		1 and 2 years	Yes
Secondary	Target vessel revascularization (ischemia- and clinically-driven)		1 and 2 years	No
Secondary	Target lesion revascularization (ischemia- and clinically-driven)		1 and 2 years	No
Secondary	Stent thrombosis (Academic Research Consortium criteria)		1 and 2 years	Yes
Secondary	In-stent and in-segment late loss on angiographic follow-up		1 year	No
Secondary	In-stent and in-segment restenosis rate		1 year	No
Secondary	Incidence and angiographic pattern of restenosis		1 year	No
Secondary	Canadian Cardiovascular Society Classification status		1 and 2 years	Yes
Secondary	The number of anti-angina medication		1 and 2 years	No
Secondary	Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group		Baseline (day 0)	No
Secondary	Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)		2 years	Yes