IRIS Ultimaster Cohort in the IRIS-DES Registry (IRISUltimaster)

Evaluation of Effectiveness and Safety of Ultimaster® Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Ultimaster stent

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• South Korea
  • Bucheon-si, South Korea
    • Sejong General Hospital
  • Chuncheon, South Korea
    • Gangwon National Univ. Hospital
  • Daegu, South Korea
    • Keimyung University Dongsan Medical Center
  • Daegu, South Korea
    • Daegu Catholic University Medical Center
  • Gangneung, South Korea
    • GangNeung Asan Hospital
  • Ilsan, South Korea
    • Inje University Ilsan Paik Hospital
  • Kwangju, South Korea
    • Kwangju Christian hospital
  • Pusan, South Korea
    • Pusan National University Hospital
  • Seoul, South Korea
    • Asan Medical Center
  • Seoul, South Korea
    • The Catholic Univ. of Korea Seoul St. Mary's Hospital
  • Seoul, South Korea
    • The Catholic University of Korea St. Paul's Hospital
  • Seoul, South Korea
    • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • Suwon, South Korea
    • The Catholic University of Korea St. Vincent's Hospital
  • Ulsan, South Korea
    • Ulsan University Hospital
  • Wŏnju, South Korea
    • WonJu Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with Ultimaster stent

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ultimaster stent	Device: Ultimaster stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite event	The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All death		5years
Cardiac death		5years
Myocardial infarction		5years
Composite event of death or myocardial infarction		5years
Composite event of cardiac death or myocardial infarction		5years
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 %	5years
Target Lesion revascularization	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.	5years
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;	5years
Stroke		5years
Procedural success	Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death	3days

Collaborators and Investigators

• Sponsor: Duk-Woo Park, MD
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2016
• Primary Completion (Actual): July 24, 2020
• Study Completion (Actual): August 8, 2024

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimated): March 25, 2016

Study Record Updates

• Last Update Posted (Estimated): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; drug eluting stent; real world data
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: AMCCV2016-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No