Evaluation of Effectiveness and Safety of XIENCE PRIME Stent (IRIS-PRIME)
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01348399
- Lead Sponsor
- Seung-Jung Park
- 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)
- Detailed Description
This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of XIENCE PRIME stents versus other DESs in patients with coronary artery disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
- 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.
- Patients with a mixture of other DESs
- Terminal illness with life expectancy <1 year
- Patients presented with cardiogenic shock
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) 12 months post procedure
- Secondary Outcome Measures
Name Time Method Death (all cause and cardiac) yearly up to 5 years MI yearly up to 5 years TVR yearly up to 5 years Target-lesion revascularization (TLR) yearly up to 5 years Stent thrombosis (ARC criteria) yearly up to 5 years Composite of death or MI yearly up to 5 years Composite of cardiac death or MI yearly up to 5 years Procedural success (defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization) At discharge from the index hospitalization
Trial Locations
- Locations (29)
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Soonchunhyang Univ. Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, 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
The Catholic University of Korea, Daejeon ST. Mary's Hospital
🇰🇷Daejeon, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
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