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

Primary Purpose

Coronary Artery Stenosis

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)
Pressure wire(Radi Medical Systems)
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring intravascular ultrasound, fractional flow reserve

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keimyung university Dongsan medical center
  • Inje University
  • Korea University Guro Hospital
  • Seoul National University Boramae Medical Center
  • Seoul national university hospital
  • Yensei University Gangnam Severance Hospital
  • Ajou University Medical Center
  • Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intravascular ultrasound

Fractional flow reserve

Arm Description

Outcomes

Primary Outcome Measures

Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)

Secondary Outcome Measures

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

Full Information

First Posted
August 3, 2010
Last Updated
February 11, 2014
Sponsor
Ajou University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01175863
Brief Title
Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery Disease
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis
Keywords
intravascular ultrasound, fractional flow reserve

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravascular ultrasound
Arm Type
Active Comparator
Arm Title
Fractional flow reserve
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)
Other Intervention Name(s)
Galaxy (Boston Scientific), Virtual histology (Volcano)
Intervention Description
minimal lumen area on Intravascular ultrasound
Intervention Type
Device
Intervention Name(s)
Pressure wire(Radi Medical Systems)
Other Intervention Name(s)
Pressure wire (Radi Medical Systems)
Intervention Description
Fractional flow reserve measured by pressure wire
Primary Outcome Measure Information:
Title
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cardiac death
Time Frame
1 and 2 years
Title
Myocardial infarction (MI)
Time Frame
1 and 2 years
Title
Composite of cardiac death or myocardial infarction
Time Frame
1 and 2 years
Title
Target vessel revascularization (ischemia- and clinically-driven)
Time Frame
1 and 2 years
Title
Target lesion revascularization (ischemia- and clinically-driven)
Time Frame
1 and 2 years
Title
Stent thrombosis (Academic Research Consortium criteria)
Time Frame
1 and 2 years
Title
In-stent and in-segment late loss on angiographic follow-up
Time Frame
1 year
Title
In-stent and in-segment restenosis rate
Time Frame
1 year
Title
Incidence and angiographic pattern of restenosis
Time Frame
1 year
Title
Canadian Cardiovascular Society Classification status
Time Frame
1 and 2 years
Title
The number of anti-angina medication
Time Frame
1 and 2 years
Title
Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group
Time Frame
Baseline (day 0)
Title
Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sejung-Jea Tahk, MD, PhD
Organizational Affiliation
Ajou University Medical Center, Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung university Dongsan medical center
City
Daegu
Country
Korea, Republic of
Facility Name
Inje University
City
Ilsan
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul national university hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yensei University Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Medical Center
City
Suwon
Country
Korea, Republic of
Facility Name
Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital
City
Wonju
Country
Korea, Republic of

12. IPD Sharing Statement

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

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