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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01366404
Acronym
IRIS FFR
Enrollment
20000
Registered
2011-06-06
Start date
2011-06-01
Completion date
2037-04-01
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

FFR

Brief 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.

Detailed description

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

Interventions

None listed

Sponsors

Seung-Jung Park
Lead SponsorOTHER
CardioVascular Research Foundation, Korea
CollaboratorOTHER
Abbott Medical Devices
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Target vessel failure2 year after index FFR measurement
composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate eventsat 2 year after index FFR measurement

Secondary

MeasureTime frame
Death (all cause and cardiac)at 2 year after index FFR measurement
MIat 2 year after index FFR measurement
Target vessel revascularizationat 2 year after index FFR measurement
Target lesion revascularizationat 2 year after index FFR measurement
Any re-hospitalization with a cardiac cause2 year follow-up after index FFR measurement
cardiac death and myocardial infarction2 year follow-up after index FFR measurement
stented lesion related event including death, myocardial infarction, repeat revascularization2 year follow-up after index FFR measurement
stroke2 year follow-up after index FFR measurement
stent thrombosis2 year follow-up after index FFR measurement
anginal status2 year follow-up after index FFR measurement
number of anti-anginal medication prescribed2 year follow-up after index FFR measurement
complication of FFR measurement2 year follow-up after index FFR measurement
clinical predictors of events2 year follow-up after index FFR measurement
change in plaque composition (%necrotic core volume) in target segment2 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 volume2 year follow-up after index FFR measurement
change in IVUS-measured MLA2 year follow-up after index FFR measurement
change in FFR2 year follow-up after index FFR measurement

Countries

South Korea

Contacts

CONTACTSeung-Jung Park, MD, PhD
sjpark@amc.seoul.kr
CONTACTJung-min Ahn, MD
drjmahn@gmail.com
PRINCIPAL_INVESTIGATORSeung-Jung Park, MD,PhD

Asan Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026