RecruitingNCT01366404
Study of the Natural History of FFR Guided Percutaneous Coronary Intervention
A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention
Sponsor
Seung-Jung Park
Enrollment
20,000 participants
Start Date
Jun 1, 2011
Study Type
OBSERVATIONAL
Conditions
Summary
About 20,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 years clinical and imaging follow-up.
Eligibility
Min Age: 35 Years
Inclusion Criteria3
- Age 35 years and older
- FFR measurement on one and more coronary artery stenosis
- Willing and able to provide informed, written consent
Exclusion Criteria10
- Stenosis with TIMI<3 flow
- Graft vessel
- Ejection fraction < 30%
- Angiographic evidence of extreme tortuosity or calcified coronary vessels
- Suspected coronary spasm even after sufficient nitrate injected
- Life expectancy <2 year
- Planned cardiac surgery or planned major non cardiac surgery
- Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study
- visually-estimated angiographic reference segment diameter of <2.75mm or >4.0mm
- Inappropriate for IVUS/VH/OCT procedures : inability for imaging wire or catheter to pass through the tight stenosis, severe calcification, angulation
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Locations(29)
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NCT01366404
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