IRIS-Synergy Cohort in the IRIS-DES Registry

N/AActive Not RecruitingNCT02720419

Jung-min Ahn3,000 enrolled

Overview

The purpose of this study is to evaluate the relative effectiveness and safety of Synergy stent compared to other drug eluting stents.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 19 and more * Intervention with Synergy stent * Agreed with written informed consent form Exclusion Criteria: * Intervention with Synergy stent and other drug eluting stent at the same time * Life expectancy of 1year and under * Cardiac shock

Locations (28)

Outcomes

Primary Outcomes

Composite event

The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)

Time frame: 1 year

Secondary Outcomes

All death

Time frame: 5 years

Cardiac death

Time frame: 5 years

Myocardial infarction

Time frame: 5 years

Composite event of death or myocardial infarction

Time frame: 5 years

Composite event of cardiac death or myocardial infarction

Time frame: 5 years

Target vessel revascularization

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 %

Time frame: 5 years

Target lesion revascularization

Data from ClinicalTrials.gov

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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.

Stent thrombosis

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;

Time frame: 5 years