Study Stopped
Early termination due to low enrollment
Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions
IRISFFRTandem
A Multicenter, Prospective Cohort to Evaluate the Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions
1 other identifier
observational
438
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2016
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
June 13, 2016
CompletedStudy Start
First participant enrolled
July 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2026
CompletedApril 15, 2026
April 1, 2026
9.7 years
June 8, 2016
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target vessel failure
defined as composite event of cardiac death, non-fatal myocardial infarction, target vessel revascularization
2 years
Secondary Outcomes (15)
all cause death
5 years
cardiac death
5 years
myocardial infarction
5 years
target vessel revascularization
5 years
target lesion revascularization
5 years
- +10 more secondary outcomes
Study Arms (1)
Tandem lesion evaluated by FFR
Interventions
Eligibility Criteria
patients with tandem lesion evaluated by FFR
You may qualify if:
- Tandem lesion evaluated by FFR
- Written consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (12)
Asan Medical Center
Seoul, Songpa-gu, 138-736, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Gangwon National Univ. Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Inje University Ilsan Paik Hospital
Ilsan, South Korea
Bundang CHA Hospital
Seongnam, South Korea
Seoul National University Bundang hospital
Seongnam, South Korea
Seoul National University hospital
Seoul, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor of medicine
Study Record Dates
First Submitted
June 8, 2016
First Posted
June 13, 2016
Study Start
July 25, 2016
Primary Completion
April 13, 2026
Study Completion
April 13, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04