Coronary Artery Disease Clinical Trial
— IRIS-PREMIEROfficial title:
Evaluation of Effectiveness and Safety of Promus PREMIER in Routine Clinical Practice; A Multicenter, Phase-IV, Prospective Observational Study
| NCT number | NCT02060968 |
| Other study ID # | AMCCV2014-03 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 2014 |
| Est. completion date | June 2021 |
| Verified date | September 2021 |
| Source | Asan Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to evaluate effectiveness and safety of Promus PREMIER in Routine Clinical Practice
| Status | Completed |
| Enrollment | 2006 |
| Est. completion date | June 2021 |
| Est. primary completion date | June 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | Inclusion Criteria: - Age 20 and more - Intervention with Promus PREMIER everolimus eluting coronary stent - Agreed with written informed consent form Exclusion Criteria: - Intervention with Promus PREMIER everolimus eluting coronary stent and other drug eluting stent at the same time - Life expectancy of 1year and under - Cardiac shock |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang | |
| Korea, Republic of | Soon Chun Hyang University Hospital Cheonan | Cheonan | |
| Korea, Republic of | Chungbuk National University Hospital | Cheongju | |
| Korea, Republic of | Gangwon National Univ. Hospital | Chuncheon | |
| Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
| 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 | Gachon University Gil Hospital | Incheon | |
| Korea, Republic of | Kwangju Christian Hospital | Kwangju | |
| Korea, Republic of | Inje University Pusan Paik Hospital | Pusan | |
| Korea, Republic of | Kosin University Hospital | Pusan | |
| Korea, Republic of | Pusan National University Hospital | Pusan | |
| Korea, Republic of | Asan Medical Hospital | Seoul | |
| Korea, Republic of | Eulji General Hospital | Seoul | |
| Korea, Republic of | Kangdong Sacred Heart Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Kyunghee University Medical Center | 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 | The Catholic University of Korea Uijeongbu St. Mary's Hospital | Uijeongbu | |
| Korea, Republic of | Ulsan University Hospital | Ulsan | |
| Korea, Republic of | Pusan National University Yangsan Hospital | Yangsan |
| Lead Sponsor | Collaborator |
|---|---|
| Seung-Jung Park | Boston Scientific Korea Co. Ltd, CardioVascular Research Foundation, Korea |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Composite event rate | Death, non fatal myocardial infarction, Target Vessel Revascularization | 1year | |
| Secondary | All death | 5year | ||
| Secondary | Cardiac death | 5year | ||
| Secondary | Myocardial infarction | 5year | ||
| Secondary | Composite event of death or myocardial infarction | 5year | ||
| Secondary | Composite event of cardiac death or myocardial infarction | 5year | ||
| Secondary | Target Vessel revascularization | 5year | ||
| Secondary | Target lesion revascularization | 5year | ||
| Secondary | Stent thrombosis by an Academic Research Consortium (ARC) criteria | 5year | ||
| Secondary | Stroke | 5year | ||
| Secondary | Procedural success | defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization participants will be followed for the duration of hospital stay, an expected average of 3days. | 3day |
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