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NCT Number: NCT01366404

Study of the Natural History of FFR Guided Percutaneous Coronary Intervention

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallym University Sacred Heart Hospital, Anyang, South Korea

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Target vessel failure

    Time frame: 2 year after index FFR measurement

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

    Time frame: at 2 year after index FFR measurement

Secondary outcomes

  1. Death (all cause and cardiac)

    Time frame: at 2 year after index FFR measurement

  2. MI

    Time frame: at 2 year after index FFR measurement

  3. Target vessel revascularization

    Time frame: at 2 year after index FFR measurement

  4. Target lesion revascularization

    Time frame: at 2 year after index FFR measurement

  5. Any re-hospitalization with a cardiac cause

    Time frame: 2 year follow-up after index FFR measurement

  6. cardiac death and myocardial infarction

    Time frame: 2 year follow-up after index FFR measurement

  7. stented lesion related event including death, myocardial infarction, repeat revascularization

    Time frame: 2 year follow-up after index FFR measurement

  8. stroke

    Time frame: 2 year follow-up after index FFR measurement

  9. stent thrombosis

    Time frame: 2 year follow-up after index FFR measurement

  10. anginal status

    Time frame: 2 year follow-up after index FFR measurement

  11. number of anti-anginal medication prescribed

    Time frame: 2 year follow-up after index FFR measurement

  12. complication of FFR measurement

    Time frame: 2 year follow-up after index FFR measurement

  13. clinical predictors of events

    Time frame: 2 year follow-up after index FFR measurement

  14. change in plaque composition (%necrotic core volume) in target segment

    Time frame: 2 year follow-up after index FFR measurement

  15. change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography)

    Time frame: 2 year follow-up after index FFR measurement

  16. change in total atheroma volume and percent atheroma volume

    Time frame: 2 year follow-up after index FFR measurement

  17. change in IVUS-measured MLA

    Time frame: 2 year follow-up after index FFR measurement

  18. change in FFR

    Time frame: 2 year follow-up after index FFR measurement

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-min Ahn, MD

CONTACT

[email protected]

Seung-Jung Park, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • Abbott Medical Devices
  • CardioVascular Research Foundation, Korea

Registry information

Official study title

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

Acronym: IRIS FFR

Important dates

Study start
2011
Primary completion
2037
Study completion
2037
First posted
Jun 6, 2011
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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