Effect of FFR Guided Percutaneous Coronary Intervention in Coronary Tandem Lesions

Percutaneous Transluminal Coronary Angioplasty Clinical Trial

— IRISFFRTandem  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02797561
• Other study ID #: AMCCV2016-12
• Status: Recruiting
• Start date: July 25, 2016
• Est. completion date: December 31, 2027

Study information

• Verified date: July 2023
• Source: Asan Medical Center
• Contact: Seung-jung Park, MD
• Email: sjpark[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2027
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Percutaneous Transluminal Coronary Angioplasty

Intervention

Other:
• 5 year Follow-up

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon
Korea, Republic of	Gangwon National Univ. Hospital	Chuncheon
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Bundang CHA Hospital	Seongnam
Korea, Republic of	Seoul National University Bundang hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Seoul National University hospital	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target vessel failure	defined as composite event of cardiac death, non-fatal myocardial infarction, target vessel revascularization	2 years
Secondary	all cause death		5 years
Secondary	cardiac death		5 years
Secondary	myocardial infarction		5 years
Secondary	target vessel revascularization		5 years
Secondary	target lesion revascularization		5 years
Secondary	Cardiac rehospitalization		5 years
Secondary	Cardiac death and myocardial infarction		5 years
Secondary	death, myocardial lnfarction, revascularization	related with stented lesion	5 years
Secondary	stroke		5 years
Secondary	stent thrombosis		5 years
Secondary	angina		5 years
Secondary	number of antianginal medications		5 years
Secondary	complications with FFR		5 years
Secondary	clinical predictors of events		5 years
Secondary	functional index	IMR(index of microcirculatory resistance), CFR(CFRthermo)	5 years