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Trial record 9 of 89 for:    Recruiting, Not yet recruiting, Available Studies | Angioplasty

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

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ClinicalTrials.gov Identifier: NCT02797561
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
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 2020
Estimated Study Completion Date : June 2023

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)



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02797561


Contacts
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Contact: Seung-jung Park, MD sjpark@amc.seoul.kr
Contact: Jung-hee Ham, Project leader cvcrc5@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Contact: Seung-Jung Park, MD       sjpark@amc.seoul.kr   
Principal Investigator: Seung-Jung Park, MD         
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon, Korea, Republic of
Contact: Nae-Hee Lee, MD       naeheelee@naver.com   
Principal Investigator: Nae-Hee Lee, MD         
Gangwon National Univ. Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Bong-Ki Lee, MD       mdbklee@kangwon.ac.kr   
Principal Investigator: Bong-Ki Lee, MD         
Chungnam National University Hospital Recruiting
Dae-jeon, Korea, Republic of
Contact: Si-Wan Choi, MD       siwanc@cnu.ac.kr   
Principal Investigator: Si-wan Choi, MD         
Daegu Catholic University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Jin-bae Lee, MD       jblee@cu.ac.kr   
Principal Investigator: Jin-bae Lee, MD         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Chang-Wook Nam, MD       ncwcv@dsmc.or.kr   
Principal Investigator: Chang-Wook Nam, MD         
Gangneung Asan Hospital Recruiting
Gangneung, Korea, Republic of
Contact: Sang-yong Yoo, MD       bovio@naver.com   
Principal Investigator: Sang-yong Yoo, MD         
Inje University Ilsan Paik Hospital Recruiting
Ilsan, Korea, Republic of
Contact: Joon-hyung Do, MD       joon.doh@gmail.com   
Principal Investigator: Joon-hyung Do, MD         
Kangbuk Samsung Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Jong-young Lee, MD       jyleeheart@naver.com   
Principal Investigator: Jong-young Lee, MD         
Seoul National University hospital Recruiting
Seoul, Korea, Republic of
Contact: Bon-kwon Koo, MD       bkkoo@snu.ac.kr   
Principal Investigator: Bon-kwon Koo, MD         
Bundang CHA Hospital Recruiting
Sungnam, Korea, Republic of
Contact: Won-jang Kim, MD       mdwjkim@gmail.com   
Principal Investigator: Won-jang Kim, MD         
Seoul National University Bundang hospital Recruiting
Sungnam, Korea, Republic of
Contact: In-Ho Chae, MD       ihchae@snu.ac.kr   
Principal Investigator: In-Ho Chae, MD         
Wonju Severance Christian Hospital Recruiting
Wonju, Korea, Republic of
Contact: Jung-han Yoon, MD       jyoon@yonsei.ac.kr   
Principal Investigator: Jung-han Yoon, MD         
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of
Contact: Jun-hong Kim, MD       junehongk@gmail.com   
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
ClinicalTrials.gov Identifier: NCT02797561     History of Changes
Other Study ID Numbers: AMCCV2016-12
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Seung-Jung Park, Asan Medical Center:
Fractional flow reserve
Tandem
Percutaneous Coronary Intervention