NCT Number: NCT02719106
IRIS Ultimaster Cohort in the IRIS-DES Registry
The purpose of this study is to evaluate the relative effectiveness and safety of Ultimaster stent compared to other drug eluting stents.
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Conditions
Age range
19 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Sejong General hospital, Bucheon-si, South Korea
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age 19 and more
- Intervention with Ultimaster stent
- Agreed with written informed consent form
Exclusion criteria
- Intervention with Ultimaster stent and other drug eluting stent at the same time
- Life expectancy of 1year and under
- Cardiac shock
Treatment and study plan
Primary outcomes
-
Composite event
Time frame: 1year
The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)
Secondary outcomes
-
All death
Time frame: 5years
-
Cardiac death
Time frame: 5years
-
Myocardial infarction
Time frame: 5years
-
Composite event of death or myocardial infarction
Time frame: 5years
-
Composite event of cardiac death or myocardial infarction
Time frame: 5years
-
Target Vessel revascularization
Time frame: 5years
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 %
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Target Lesion revascularization
Time frame: 5years
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.
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Stent thrombosis
Time frame: 5years
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;
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Stroke
Time frame: 5years
-
Procedural success
Time frame: 3days
Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death
Sponsors and collaborators
Lead sponsor
Duk-Woo Park, MD
Other
Collaborators
- CardioVascular Research Foundation, Korea
Registry information
Official study title
Evaluation of Effectiveness and Safety of Ultimaster® Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Acronym: IRISUltimaster
Important dates
- Study start
- 2016
- Primary completion
- 2020
- Study completion
- 2024
- First posted
- Mar 25, 2016
- Registry last updated
- Dec 29, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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