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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02797561
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : June 18, 2020
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

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

Condition or disease Intervention/treatment
Percutaneous Transluminal Coronary Angioplasty Other: 5 year Follow-up

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Prospective Cohort to Evaluate the Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions
Actual Study Start Date : July 25, 2016
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2027

Group/Cohort Intervention/treatment
Tandem lesion evaluated by FFR Other: 5 year Follow-up

Primary Outcome Measures :
  1. Target vessel failure [ Time Frame: 2 years ]
    defined as composite event of cardiac death, non-fatal myocardial infarction, target vessel revascularization

Secondary Outcome Measures :
  1. all cause death [ Time Frame: 5 years ]
  2. cardiac death [ Time Frame: 5 years ]
  3. myocardial infarction [ Time Frame: 5 years ]
  4. target vessel revascularization [ Time Frame: 5 years ]
  5. target lesion revascularization [ Time Frame: 5 years ]
  6. Cardiac rehospitalization [ Time Frame: 5 years ]
  7. Cardiac death and myocardial infarction [ Time Frame: 5 years ]
  8. death, myocardial lnfarction, revascularization [ Time Frame: 5 years ]
    related with stented lesion

  9. stroke [ Time Frame: 5 years ]
  10. stent thrombosis [ Time Frame: 5 years ]
  11. angina [ Time Frame: 5 years ]
  12. number of antianginal medications [ Time Frame: 5 years ]
  13. complications with FFR [ Time Frame: 5 years ]
  14. clinical predictors of events [ Time Frame: 5 years ]
  15. functional index [ Time Frame: 5 years ]
    IMR(index of microcirculatory resistance), CFR(CFRthermo)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with tandem lesion evaluated by FFR

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02797561

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Contact: Seung-jung Park, MD
Contact: Jung-hee Ham, Project leader

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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Contact: Seung-Jung Park, MD   
Principal Investigator: Seung-Jung Park, MD         
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon, Korea, Republic of
Contact: Nae-Hee Lee, MD   
Principal Investigator: Nae-Hee Lee, MD         
Gangwon National Univ. Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Bong-Ki Lee, MD   
Principal Investigator: Bong-Ki Lee, MD         
Daegu Catholic University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Jin-bae Lee, MD   
Principal Investigator: Jin-bae Lee, MD         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Chang-Wook Nam, MD   
Principal Investigator: Chang-Wook Nam, MD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Si-Wan Choi, MD   
Principal Investigator: Si-wan Choi, MD         
Gangneung Asan Hospital Recruiting
Gangneung, Korea, Republic of
Contact: Sang-yong Yoo, MD   
Principal Investigator: Sang-yong Yoo, MD         
Inje University Ilsan Paik Hospital Recruiting
Ilsan, Korea, Republic of
Contact: Joon-hyung Do, MD   
Principal Investigator: Joon-hyung Do, MD         
Bundang CHA Hospital Recruiting
Seongnam, Korea, Republic of
Contact: Won-jang Kim, MD   
Principal Investigator: Won-jang Kim, MD         
Seoul National University Bundang hospital Recruiting
Seongnam, Korea, Republic of
Contact: In-Ho Chae, MD   
Principal Investigator: In-Ho Chae, MD         
Kangbuk Samsung Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Jong-young Lee, MD   
Principal Investigator: Jong-young Lee, MD         
Seoul National University hospital Recruiting
Seoul, Korea, Republic of
Contact: Bon-kwon Koo, MD   
Principal Investigator: Bon-kwon Koo, MD         
Wonju Severance Christian Hospital Recruiting
Wonju, Korea, Republic of
Contact: Jung-han Yoon, MD   
Principal Investigator: Jung-han Yoon, MD         
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of
Contact: Jun-hong Kim, MD   
Principal Investigator: Jun-hong Kim, MD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
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Responsible Party: Seung-Jung Park, professor of medicine, Asan Medical Center Identifier: NCT02797561    
Other Study ID Numbers: AMCCV2016-12
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Seung-Jung Park, Asan Medical Center:
Fractional flow reserve
Percutaneous Coronary Intervention