Prognosis of Coronary Stenosis Based on Intracoronary Imaging; A Multicenter, Prospective Observational Study

Coronary Artery Disease Clinical Trial

— IRIS imaging  

Official title:

Prognosis of Coronary Stenosis Based on Intracoronary Imaging; A Multicenter, Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02792075
• Other study ID #: AMCCV2016-09
• Status: Recruiting
• Start date: July 2016
• Est. completion date: June 2029

Study information

• Verified date: April 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 prognosis of coronary stenosis based on intracoronary Imaging.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: June 2029
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients with intracoronary imaging

• Written consent

Exclusion Criteria:

• Severe calcification and/or severe tortuosity

• Lesion with previous bypass graft surgery (CABG)

• Left ventricular ejection fraction less than 30 %

• Coronary spasm

• Life expectancy less than 2 years

• Pregnancy or breast-feeding

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Stenosis

Intervention

Other:
• 5-year Follow-up

Locations

Country	Name	City	State
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Jeju national university hospital	Jeju
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Chung-Ang university hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

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 myocardiac infarction, target vessel revascularization	2 years
Secondary	All-cause death		5 years
Secondary	Cardiac death		5 years
Secondary	Number of myocardial infarction events	Q wave myocardial infarction or non Q wave myocardial infarction	5 years
Secondary	Composite event of death or myocardial infarction		5 years
Secondary	Composite event of cardiac death or myocardial infarction		5 years
Secondary	Target Vessel revascularization		5 years
Secondary	Target Lesion revascularization		5 years
Secondary	Number of stent thrombosis events	DEFINITE stent thrombosis : acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE stent thrombosis : unexplained death within 30 days or target-vessel infarction without angiographic information Academic Research Consortium (ARC) stent thrombosis is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute stent thrombosis: 0-24 hours after stent implantation; Subacute stent thrombosis: >24 hours to 30 days post; late stent thrombosis: >30 days to 1 year post; Very late stent thrombosis: >1 year post;	5 years
Secondary	Number of stroke		5 years
Secondary	Procedural success	Defined as mean lesion diameter stenosis less than 30% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death	7 days