Evaluation of Effectiveness and Safety of XIENCE PRIME Stent (IRIS-PRIME)
1 other identifier
observational
2,000
1 country
29
Brief Summary
The objective of this study is to evaluate effectiveness and safety of XIENCE PRIME stent in the "real world" daily practice as compared with other drug eluting stents (DESs)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2011
Longer than P75 for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 4, 2011
CompletedFirst Posted
Study publicly available on registry
May 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJune 20, 2018
June 1, 2018
3.3 years
May 4, 2011
June 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR)
12 months post procedure
Secondary Outcomes (22)
Death (all cause and cardiac)
one month
Death (all cause and cardiac)
6 months
Death (all cause and cardiac)
yearly up to 5 years
MI
one month
MI
6 months
- +17 more secondary outcomes
Study Arms (1)
XIENCE PRIME stents
Eligibility Criteria
Patients receiving XIENCE PRIME stents.
You may qualify if:
- Patients receiving XIENCE PRIME stents.
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
You may not qualify if:
- Patients with a mixture of other DESs
- Terminal illness with life expectancy \<1 year
- Patients presented with cardiogenic shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
- Abbottcollaborator
Study Sites (29)
Hallym University Sacred Heart Hospital
Anyang, South Korea
Soonchunhyang Univ. Bucheon Hospital
Bucheon-si, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Gangwon National Univ. Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
National Health Insurance Corporation Ilsan Hospital
Ilsan, South Korea
Presbyterian Medical Center
Jeonju, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Kwangju Christian Hospital
Kwangju, South Korea
Inje University Pusan Paik Hospital
Pusan, South Korea
Pusan National University Hospital
Pusan, South Korea
Pusan National University Yangsan Hospital
Pusan, South Korea
Bundang Cha Medical Center
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Kangnam Sacred Heart Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyunghee University Hospital at Gangdong
Seoul, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea
St.carollo Hospital
Suncheon, South Korea
The Catholic University of Korea St. Vincent's Hospital
Suwon, South Korea
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
Ulsan University Hospital
Ulsan, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, MD, PhD
Asan Medical Center
- PRINCIPAL INVESTIGATOR
Ki Bae Seung, MD, PhD
Seoul St. Mary's Hospital, Catholic University of Korea
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
Study Record Dates
First Submitted
May 4, 2011
First Posted
May 5, 2011
Study Start
April 1, 2011
Primary Completion
July 1, 2014
Study Completion
September 1, 2017
Last Updated
June 20, 2018
Record last verified: 2018-06