IRIS-Synergy Cohort in the IRIS-DES Registry
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT02720419
- Lead Sponsor
- Jung-min Ahn
- Brief Summary
The purpose of this study is to evaluate the relative effectiveness and safety of Synergy stent compared to other drug eluting stents.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- Age 19 and more
- Intervention with Synergy stent
- Agreed with written informed consent form
- Intervention with Synergy stent and other drug eluting stent at the same time
- Life expectancy of 1year and under
- Cardiac shock
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite event 1 year The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)
- Secondary Outcome Measures
Name Time Method Stroke 5 years Procedural success 3 days Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death
All death 5 years Composite event of death or myocardial infarction 5 years Cardiac death 5 years Myocardial infarction 5 years Composite event of cardiac death or myocardial infarction 5 years Target lesion revascularization 5 years Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Target vessel revascularization 5 years Defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. Clinical-driven Clinically indicated angiography at follow-up shows a percent diameter stenosis ≥ 50% (core lab QCA assessment) and if one of the following occurs: (1) a positive history of recurrent angina pectoris, presumably related to the target vessel; (2) objective signs of ischemia at rest (ECG changes) of during exercise test (or equivalent), presumably related to the target vessel; (3) abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve). Ischemia-driven if one of followings of above-mentioned symptom (clinical-driven) or sign of ischemia or diameter stenosis ≥ 70 %
Stent thrombosis 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;
Trial Locations
- Locations (28)
Hallym University Chuncheon Sacred Heart Hospital
🇰🇷Chuncheon, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Busan, Korea, Republic of
Gangwon National Univ. Hospital
🇰🇷Chuncheon, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Incheon St. Mary's Hospital, The Catholic University of Korea
🇰🇷Incheon, Korea, Republic of
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Soon Chun Hyang University Hospital
🇰🇷Cheonan, Korea, Republic of
Haeundae paik hospital, inje university
🇰🇷Busan, Korea, Republic of
Inje university Pusan Paik hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
The Catholic University of Korea, Daejeon ST. Mary's Hospital
🇰🇷Daejeon, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Kwangju Christian Hospital
🇰🇷Kwangju, Korea, Republic of
Cheju Halla General Hopsital
🇰🇷Jeju, Korea, Republic of
Seoul university Bundang hospital
🇰🇷Seongnam, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Kyung-Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Eulji general hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, St. Paul's hospital
🇰🇷Seoul, Korea, Republic of