Clinical trial NCT02797561: Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions
Official title: A Multicenter, Prospective Cohort to Evaluate the Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Percutaneous Transluminal Coronary Angioplasty
Keywords: Fractional flow reserve
Tandem
Percutaneous Coronary Intervention
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-06-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with tandem lesion evaluated by FFR

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.


Eligibility 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

Primary outcomes:
measure: Target vessel failure
timeFrame: 2 years
Secondary outcomes:
measure: all cause death
timeFrame: 5 years
measure: cardiac death
timeFrame: 5 years
measure: myocardial infarction
timeFrame: 5 years
measure: target vessel revascularization
timeFrame: 5 years
measure: target lesion revascularization
timeFrame: 5 years
measure: Cardiac rehospitalization
timeFrame: 5 years
measure: Cardiac death and myocardial infarction
timeFrame: 5 years
measure: death, myocardial lnfarction, revascularization
timeFrame: 5 years
measure: stroke
timeFrame: 5 years
measure: stent thrombosis
timeFrame: 5 years
measure: angina
timeFrame: 5 years
measure: number of antianginal medications
timeFrame: 5 years
measure: complications with FFR
timeFrame: 5 years
measure: clinical predictors of events
timeFrame: 5 years
measure: functional index
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
References: