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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Seung-Jea Tahk, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT01175863
First received: August 3, 2010
Last updated: February 11, 2014
Last verified: February 2014

August 3, 2010
February 11, 2014
February 2010
May 2014   (final data collection date for primary outcome measure)
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01175863 on ClinicalTrials.gov Archive Site
  • Cardiac death [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (MI) [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or myocardial infarction [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (ischemia- and clinically-driven) [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia- and clinically-driven) [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • Stent thrombosis (Academic Research Consortium criteria) [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment late loss on angiographic follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • In-stent and in-segment restenosis rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Incidence and angiographic pattern of restenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Canadian Cardiovascular Society Classification status [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
  • The number of anti-angina medication [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
  • Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (MI) [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (ischemia- and clinically-driven) [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia- and clinically-driven) [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • Stent thrombosis (Academic Research Consortium criteria) [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment late loss on angiographic follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • In-stent and in-segment restenosis rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Incidence and angiographic pattern of restenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Canadian Cardiovascular Society Classification status [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
  • The number of anti-angina medication [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group [ Time Frame: Baseline (day 0) ] [ Designated as safety issue: No ]
  • Major adverse cardiac events (composite of cardiac death, MI and target vessel revascularization) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Stenosis
  • 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)
  • Device: Pressure wire(Radi Medical Systems)
    Fractional flow reserve measured by pressure wire
    Other Name: Pressure wire (Radi Medical Systems)
  • Active Comparator: Intravascular ultrasound
    Intervention: Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)
  • Active Comparator: Fractional flow reserve
    Intervention: Device: Pressure wire(Radi Medical Systems)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1400
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01175863
FAVOR
Yes
Seung-Jea Tahk, Ajou University School of Medicine
Ajou University School of Medicine
Not Provided
Principal Investigator: Sejung-Jea Tahk, MD, PhD Ajou University Medical Center, Ajou University School of Medicine
Ajou University School of Medicine
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP