Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice
IRIS Sierra
1 other identifier
observational
2,000
1 country
10
Brief Summary
The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the "real world" daily practice as compared with other drug-eluting stents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedStudy Start
First participant enrolled
December 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
ExpectedJanuary 2, 2026
December 1, 2025
4.7 years
May 27, 2019
December 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
1 year
Secondary Outcomes (10)
All cause death
5 year
Cardiac death
5 year
Myocardial Infarction
5 year
Composite event rate of death or myocardial infarction (MI)
5 year
Composite event rate of cardiac death or myocardial infarction (MI)
5 year
- +5 more secondary outcomes
Study Arms (1)
Consecutive percutaneous coronary intervention
Interventions
Percutaneous coronary intervention with Xience Sierra stent
Eligibility Criteria
Patient with Xience Sierra coronary stent
You may qualify if:
- Age 19 and more
- Patient with Xience Sierra Everolimus eluting coronary stent
- Written consent
You may not qualify if:
- Intervention with Xience Sierra Everolimus eluting coronary stent and other drug eluting stent at the same time
- Life-expectancy less than 1 year
- Cardiac shock
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (10)
Dong-A Medical Center
Busan, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Gangwon National Univ. Hospital
Chuncheon, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Asan Medical Center
Seoul, South Korea
The Catholic University of Korea, Eunpyeong 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
Wonju Severance Christian Hospital
Wŏnju, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Division of Interventional Cardiology. Cardiovascular Center, Asan Medical Center. University of Ulsan, College of Medicine
Study Record Dates
First Submitted
May 27, 2019
First Posted
May 30, 2019
Study Start
December 23, 2019
Primary Completion
August 27, 2024
Study Completion (Estimated)
December 31, 2028
Last Updated
January 2, 2026
Record last verified: 2025-12