Clinical trial NCT02719106: IRIS Ultimaster Cohort in the IRIS-DES Registry
Official title: Evaluation of Effectiveness and Safety of Ultimaster® Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Keywords: real world data
percutaneous coronary intervention
drug eluting stent
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2016-03-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Ultimaster stent

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


Eligibility criteria: 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

Primary outcomes:
measure: Composite event
timeFrame: 1year
Secondary outcomes:
measure: All death
timeFrame: 5years
measure: Cardiac death
timeFrame: 5years
measure: Myocardial infarction
timeFrame: 5years
measure: Composite event of death or myocardial infarction
timeFrame: 5years
measure: Composite event of cardiac death or myocardial infarction
timeFrame: 5years
measure: Target Vessel revascularization
timeFrame: 5years
measure: Target Lesion revascularization
timeFrame: 5years
measure: Stent thrombosis
timeFrame: 5years
measure: Stroke
timeFrame: 5years
measure: Procedural success
timeFrame: 3days
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Sejong General hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National Univ. Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea Seoul St. Mary's hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Paul's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
References: