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

March 18, 2026 updated by: Seung-Jung Park

A Multicenter, Prospective Cohort to Evaluate 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • South Korea
      • Anyang, South Korea
        • Recruiting
        • Hallym University Sacred Heart Hospital
        • Contact:
          • Hyun-sook Kim, MD
        • Principal Investigator:
          • Hyun-sook Kim, MD
      • Bucheon-si, South Korea
        • Recruiting
        • Soon Chun Hyang University Hospital Bucheon
        • Contact:
          • Nae-hee Lee, MD
        • Principal Investigator:
          • Nae-hee Lee, MD
      • Cheongju-si, South Korea
        • Recruiting
        • Chungbuk National University Hospital
        • Contact:
          • Sang-yeub Lee, MD
        • Principal Investigator:
          • Sang-yeub Lee, MD
      • Chuncheon, South Korea
        • Recruiting
        • Gangwon National Univ. Hospital
        • Principal Investigator:
          • Bong-ki Kim, MD
        • Contact:
          • Bong-ki Lee, MD
      • Daegu, South Korea
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
          • Chang-wook Nam, MD
        • Principal Investigator:
          • Chang-wook Nam, MD
      • Daegu, South Korea
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
          • Hun-sik Park, MD
        • Principal Investigator:
          • Hun-sik Park, MD
      • Daegu, South Korea
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
          • Jong-seon Park, MD
        • Principal Investigator:
          • Jong-seon Park, MD
      • Daegu, South Korea
        • Recruiting
        • Daegu Catholic University Center
        • Principal Investigator:
          • Jin-bae Lee, MD
        • Contact:
          • Jin-bae Lee, MD
      • Daejeon, South Korea
        • Recruiting
        • Chungnam national university hospital
        • Contact:
          • Si-wan Choi, MD
        • Principal Investigator:
          • Si-wan Choi, MD
      • Daejeon, South Korea
        • Recruiting
        • The Catholic University of Korea, Deajeon St.Mary's hospital
        • Contact:
          • Sung-ho Her, MD
        • Principal Investigator:
          • Sung-ho Her, MD
      • Gangneung, South Korea
        • Recruiting
        • GangNeung Asan Hospital
        • Contact:
          • Sang-sig Jung, MD
        • Principal Investigator:
          • Sang-sig Jung, MD
      • Gwangju, South Korea
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
          • Young-jun Hong, MD
        • Principal Investigator:
          • Young-jun Hong, MD
      • Ilsan, South Korea
        • Recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:
          • Joon-hyung Doh, MD
        • Principal Investigator:
          • Joon-hyung Doh, MD
      • Pusan, South Korea
        • Recruiting
        • Dong-A Medical Center
        • Contact:
          • Kyung-il Park, MD
        • Principal Investigator:
          • Kyung-il Park, MD
      • Pusan, South Korea
        • Recruiting
        • Pusan National University Hospital
        • Contact:
          • Taeg-jong Hong, MD
        • Principal Investigator:
          • Taeg-jong Hong, MD
      • Seongnam, South Korea
        • Recruiting
        • Seoul university Bundang hospital
        • Contact:
          • In-ho Chae, MD
        • Principal Investigator:
          • In-ho Chae, MD
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Bon-kwon Koo, MD
        • Principal Investigator:
          • Bon-kwon Koo, MD
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Seung-jung Park, MD
      • Seoul, South Korea
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
          • Seung-un Na, MD
        • Principal Investigator:
          • Seung-un Na, MD
      • Seoul, South Korea
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
          • Do-sun Lim, MD
        • Principal Investigator:
          • Do-sun Lim, MD
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Boramae Medical Center
        • Contact:
          • Woo-young Chung, MD
        • Principal Investigator:
          • Woo-young Chung, MD
      • Seoul, South Korea
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
          • Byoung-kwon Lee, MD
        • Principal Investigator:
          • Byoung-kwon Lee, MD
      • Seoul, South Korea
        • Recruiting
        • Hallym University Kangdong Sacred Heart Hospital
        • Contact:
          • Kyoo-rok Han, MD
        • Principal Investigator:
          • Kyoo-rok Han, MD
      • Seoul, South Korea
        • Recruiting
        • Kyung-Hee University Hospital at Kangdong
        • Contact:
          • Jong-jin Kim, MD
        • Principal Investigator:
          • Jong-jin Kim, MD
      • Seoul, South Korea
        • Recruiting
        • The Catholic University of Korea, Seoul St.Mary's Hospital
        • Contact:
          • Ki-bae Seung, MD
        • Principal Investigator:
          • Ki-bae Seung, MD
      • Seoul, South Korea
        • Recruiting
        • The Catholic University of Korea, Yeouido St. Mary's Hospital
        • Contact:
          • Chul-soo Park, MD
        • Principal Investigator:
          • Chul-soo Park, MD
      • Ulsan, South Korea
        • Recruiting
        • Ulsan University Hospital
        • Contact:
          • Eun-seok Shin, MD
        • Principal Investigator:
          • Eun-seok Shin, MD
      • Wŏnju, South Korea
        • Recruiting
        • Wonju Severance Christian Hospital
        • Contact:
          • Jung-han Yoon, MD
        • Principal Investigator:
          • Jung-han Yoon, MD
      • Yangsan, South Korea
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:
          • Jun-hong Kim, MD
        • Principal Investigator:
          • Jun-hong Kim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who had FFR measurement

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
FFR
Patients who had FFR measurement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Target vessel failure
Time Frame: 2 year after index FFR measurement
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
at 2 year after index FFR measurement

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Death (all cause and cardiac)
Time Frame: at 2 year after index FFR measurement
at 2 year after index FFR measurement
MI
Time Frame: at 2 year after index FFR measurement
at 2 year after index FFR measurement
Target vessel revascularization
Time Frame: at 2 year after index FFR measurement
at 2 year after index FFR measurement
Target lesion revascularization
Time Frame: at 2 year after index FFR measurement
at 2 year after index FFR measurement
Any re-hospitalization with a cardiac cause
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
cardiac death and myocardial infarction
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
stented lesion related event including death, myocardial infarction, repeat revascularization
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
stroke
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
stent thrombosis
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
anginal status
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
number of anti-anginal medication prescribed
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
complication of FFR measurement
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
clinical predictors of events
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
change in plaque composition (%necrotic core volume) in target segment
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography)
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
change in total atheroma volume and percent atheroma volume
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
change in IVUS-measured MLA
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement
change in FFR
Time Frame: 2 year follow-up after index FFR measurement
2 year follow-up after index FFR measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seung-Jung Park

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott Medical Devices
CardioVascular Research Foundation, Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seung-Jung Park, MD,PhD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2037

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CVRF2010-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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