Prognosis of Coronary Stenosis Based on Intracoronary Imaging; A Multicenter, Prospective Observational Study
- Conditions
- Coronary Artery Disease
- Interventions
- Other: 5-year Follow-up
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4000
- Patients with intracoronary imaging
- Written consent
- 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
- Arm && Interventions
Group Intervention Description gray scale IVUS 5-year Follow-up Patients with gray-scale IVUS(Intravascular ultrasound) VH-IVUS 5-year Follow-up Patients with IVUS-derived virtual histology OCT 5-year Follow-up Patients with Optical coherence tomography NIRS 5-year Follow-up Patients with Near-infrared spectroscopy
- 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
Target Vessel revascularization 5 years 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
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
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Jeju national university hospital
🇰🇷Jeju, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang university hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of