Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions (IRISFFRTandem)

April 13, 2026 updated by: Seung-Jung Park

A Multicenter, Prospective Cohort to Evaluate the Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions

The purpose of this study is to evaluate the effect of FFR (Fractional flow reserve) guided Percutaneous Coronary Intervention in coronary tandem lesions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

438

Contacts and Locations

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

Study Locations

  • South Korea
      • Bucheon-si, South Korea
        • Soon Chun Hyang University Hospital Bucheon
      • Chuncheon, South Korea
        • Gangwon National Univ. Hospital
      • Daegu, South Korea
        • Keimyung University Dongsan Medical Center
      • Daegu, South Korea
        • Daegu Catholic University Medical Center
      • Daejeon, South Korea
        • Chungnam National University Hospital
      • Ilsan, South Korea
        • Inje University Ilsan Paik Hospital
      • Seongnam, South Korea
        • Seoul National University Bundang Hospital
      • Seongnam, South Korea
        • Bundang CHA Hospital
      • Seoul, South Korea
        • Seoul National University Hospital
      • Wŏnju, South Korea
        • Wonju Severance Christian Hospital
      • Yangsan, South Korea
        • Pusan National University Yangsan Hospital
    • Songpa-gu
      • Seoul, Songpa-gu, South Korea, 138-736
        • Asan Medical Center

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

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with tandem lesion evaluated by FFR

Description

Inclusion Criteria:

  • Tandem lesion evaluated by FFR
  • Written consent

Exclusion Criteria:

  • TIMI flow < 3
  • Grafted vessel
  • Left ventricular ejection fraction < 30%
  • Severe calcification and/or severe tortuosity
  • Uncontrolled coronary spasm
  • Life expectancy < 2 years
  • Planned high risk surgery
  • Pregnancy or breast-feeding

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
Intervention / Treatment
Tandem lesion evaluated by FFR
Other: 5 year Follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target vessel failure
Time Frame: 2 years
defined as composite event of cardiac death, non-fatal myocardial infarction, target vessel revascularization
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all cause death
Time Frame: 5 years
5 years
cardiac death
Time Frame: 5 years
5 years
myocardial infarction
Time Frame: 5 years
5 years
target vessel revascularization
Time Frame: 5 years
5 years
target lesion revascularization
Time Frame: 5 years
5 years
Cardiac rehospitalization
Time Frame: 5 years
5 years
Cardiac death and myocardial infarction
Time Frame: 5 years
5 years
death, myocardial lnfarction, revascularization
Time Frame: 5 years
related with stented lesion
5 years
stroke
Time Frame: 5 years
5 years
stent thrombosis
Time Frame: 5 years
5 years
angina
Time Frame: 5 years
5 years
number of antianginal medications
Time Frame: 5 years
5 years
complications with FFR
Time Frame: 5 years
5 years
clinical predictors of events
Time Frame: 5 years
5 years
functional index
Time Frame: 5 years
IMR(index of microcirculatory resistance), CFR(CFRthermo)
5 years

Collaborators and Investigators

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

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea

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)

July 25, 2016

Primary Completion (Actual)

April 13, 2026

Study Completion (Actual)

April 13, 2026

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimated)

June 13, 2016

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AMCCV2016-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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