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

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT02792075
• Lead Sponsor: Seung-Jung Park

Brief Summary

The purpose of this study is to evaluate the prognosis of coronary stenosis based on intracoronary Imaging.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-07
• Study Start: 2016-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-01
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Vessel Failure	2 years	defined as composite event of cardiac death, non-fatal myocardiac infarction, target vessel revascularization

Secondary Outcome Measures

Name	Time	Method
Cardiac death	5 years
All-cause death	5 years
Composite event of death or myocardial infarction	5 years
Composite event of cardiac death or myocardial infarction	5 years
Procedural success	7 days	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
Number of myocardial infarction events	5 years	Q wave myocardial infarction or non Q wave myocardial infarction
Target Lesion revascularization	5 years
Number of stent thrombosis events	5 years	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;
Number of stroke	5 years
Target Vessel revascularization	5 years

Trial Locations

Locations (15)

Asan Medical Center; 🇰🇷 Seoul, Songpa-gu, 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

Chung-Ang university hospital; 🇰🇷 Seoul, Korea, Republic of

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