Study of the Natural History of FFR Guided Percutaneous Coronary Intervention

Seung-Jung Park20,000 enrolled

Overview

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.

This is a multicenter, prospective cohort. About 20,000 patients with FFR will be enrolled at multi centres in Korea.

Study Type

OBSERVATIONAL

Enrollment

20,000

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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

Locations (29)

Outcomes

Primary Outcomes

Target vessel failure

Time frame: 2 year after index FFR measurement

composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events

Time frame: at 2 year after index FFR measurement

Secondary Outcomes

Death (all cause and cardiac)

Time frame: at 2 year after index FFR measurement

Target vessel revascularization

Time frame: at 2 year after index FFR measurement

Target lesion revascularization

Time frame: at 2 year after index FFR measurement

Any re-hospitalization with a cardiac cause