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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175863

Locations
Korea, Republic of
Keimyung university Dongsan medical center
Daegu, Korea, Republic of
Inje University
Ilsan, Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of
Yensei University Gangnam Severance Hospital
Seoul, Korea, Republic of
Seoul National University Boramae Medical Center
Seoul, Korea, Republic of
Korea University Guro 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

No publications provided

Responsible Party: Seung-Jea Tahk, MD, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01175863     History of Changes
Other Study ID Numbers: FAVOR
Study First Received: August 3, 2010
Last Updated: February 11, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ajou University School of Medicine:
intravascular ultrasound
fractional flow reserve

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014