Status:
TERMINATED
Fractional Flow Reserve (FFR) Versus Intravascular Ultrasound (IVUS) in Intermediate Coronary Artery Disease
Lead Sponsor:
Ajou University School of Medicine
Conditions:
Coronary Artery Stenosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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) guide...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT01175863
Start Date
February 1 2010
End Date
May 1 2014
Last Update
February 12 2014
Active Locations (8)
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1
Keimyung university Dongsan medical center
Daegu, South Korea
2
Inje University
Ilsan, South Korea
3
Korea University Guro Hospital
Seoul, South Korea
4
Seoul National University Boramae Medical Center
Seoul, South Korea