Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery Disease
NCT ID: NCT01175863
Last Updated: 2014-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
1400 participants
INTERVENTIONAL
2010-02-28
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intravascular ultrasound
Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)
minimal lumen area on Intravascular ultrasound
Fractional flow reserve
Pressure wire(Radi Medical Systems)
Fractional flow reserve measured by pressure wire
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Ajou University School of Medicine
OTHER
Responsible Party
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Seung-Jea Tahk
MD
Principal Investigators
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Sejung-Jea Tahk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ajou University Medical Center, Ajou University School of Medicine
Locations
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Keimyung university Dongsan medical center
Daegu, , South Korea
Inje University
Ilsan, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Seoul National University Boramae Medical Center
Seoul, , South Korea
Seoul national university hospital
Seoul, , South Korea
Yensei University Gangnam Severance Hospital
Seoul, , South Korea
Ajou University Medical Center
Suwon, , South Korea
Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital
Wŏnju, , South Korea
Countries
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Other Identifiers
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FAVOR
Identifier Type: -
Identifier Source: org_study_id
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