Study of the Natural History of FFR Guided Percutaneous Coronary Intervention (IRIS FFR)

Seung-Jung Park

Status: Enrolling

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01366404

CVRF2010-09

Details and patient eligibility

About

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.

Full description

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

Enrollment: 20,000 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20,000 participants in 1 patient group

FFR

Description:

Patients who had FFR measurement