We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01175863
First Posted: August 5, 2010
Last Update Posted: February 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seung-Jea Tahk, Ajou University School of Medicine
  Purpose
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.

Condition Intervention Phase
Coronary Artery Stenosis Device: Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound) Device: Pressure wire(Radi Medical Systems) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fractional Flow Reserve- And Intra-vascular Ultrasound-Guided Percutaneous Coronary Intervention With Drug-Eluting Stents in Intermediate Coronary Artery Lesion (FAVOR Study)

Resource links provided by NLM:


Further study details as provided by Seung-Jea Tahk, Ajou University School of Medicine:

Primary Outcome Measures:
  • Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Cardiac death [ Time Frame: 1 and 2 years ]
  • Myocardial infarction (MI) [ Time Frame: 1 and 2 years ]
  • Composite of cardiac death or myocardial infarction [ Time Frame: 1 and 2 years ]
  • Target vessel revascularization (ischemia- and clinically-driven) [ Time Frame: 1 and 2 years ]
  • Target lesion revascularization (ischemia- and clinically-driven) [ Time Frame: 1 and 2 years ]
  • Stent thrombosis (Academic Research Consortium criteria) [ Time Frame: 1 and 2 years ]
  • In-stent and in-segment late loss on angiographic follow-up [ Time Frame: 1 year ]
  • In-stent and in-segment restenosis rate [ Time Frame: 1 year ]
  • Incidence and angiographic pattern of restenosis [ Time Frame: 1 year ]
  • Canadian Cardiovascular Society Classification status [ Time Frame: 1 and 2 years ]
  • The number of anti-angina medication [ Time Frame: 1 and 2 years ]
  • Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group [ Time Frame: Baseline (day 0) ]
  • Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) [ Time Frame: 2 years ]

Estimated Enrollment: 1400
Study Start Date: February 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175863


Locations
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, Korea, Republic of
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
Principal Investigator: Sejung-Jea Tahk, MD, PhD Ajou University Medical Center, Ajou University School of Medicine
  More Information

Responsible Party: Seung-Jea Tahk, MD, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01175863     History of Changes
Other Study ID Numbers: FAVOR
First Submitted: August 3, 2010
First Posted: August 5, 2010
Last Update Posted: February 12, 2014
Last Verified: February 2014

Keywords provided by Seung-Jea Tahk, Ajou University School of Medicine:
intravascular ultrasound
fractional flow reserve

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases