Study of the Natural History of FFR Guided Percutaneous Coronary Intervention

Study Overview
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Brief Summary
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About 15,000 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.

Detailed Description
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This is a multicenter, prospective cohort. About 15,000 patients with FFR will be enrolled at multi centres in Korea.

Official Title
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A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 35 years and older FFR measurement on one and more coronary artery stenosis Willing and able to provide informed, written consent Exclusion Criteria: 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 Imaging study specific exclusion criteria 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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FFR<br>Patients who had FFR measurement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel failure |  | 2 year after index FFR measurement | 
| composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events |  | at 2 year after index FFR measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death (all cause and cardiac) |  | at 2 year after index FFR measurement | 
| MI |  | at 2 year after index FFR measurement | 
| Target vessel revascularization |  | at 2 year after index FFR measurement | 
| Target lesion revascularization |  | at 2 year after index FFR measurement | 
| Any re-hospitalization with a cardiac cause |  | 2 year follow-up after index FFR measurement | 
| cardiac death and myocardial infarction |  | 2 year follow-up after index FFR measurement | 
| stented lesion related event including death, myocardial infarction, repeat revascularization |  | 2 year follow-up after index FFR measurement | 
| stroke |  | 2 year follow-up after index FFR measurement | 
| stent thrombosis |  | 2 year follow-up after index FFR measurement | 
| anginal status |  | 2 year follow-up after index FFR measurement | 
| number of anti-anginal medication prescribed |  | 2 year follow-up after index FFR measurement | 
| complication of FFR measurement |  | 2 year follow-up after index FFR measurement | 
| clinical predictors of events |  | 2 year follow-up after index FFR measurement | 
| change in plaque composition (%necrotic core volume) in target segment |  | 2 year follow-up after index FFR measurement | 
| change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography) |  | 2 year follow-up after index FFR measurement | 
| change in total atheroma volume and percent atheroma volume |  | 2 year follow-up after index FFR measurement | 
| change in IVUS-measured MLA |  | 2 year follow-up after index FFR measurement | 
| change in FFR |  | 2 year follow-up after index FFR measurement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FFR