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NCT03967158 Clinical Trial

Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice

Coronary Artery Disease Clinical Trial

— IRIS Sierra  

Official title:
Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice; A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03967158
Other study ID # AMCCV2019-03
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 23, 2019
Est. completion date December 31, 2028

Study information
Verified date December 2023
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2000
Est. completion date December 31, 2028
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Age 19 and more - Patient with Xience Sierra Everolimus eluting coronary stent Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Xience Sierra stent
Percutaneous coronary intervention with Xience Sierra stent

Locations
Country Name City State
Korea, Republic of Dong-A Medical Center Busan
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Gangwon National Univ. Hospital Chuncheon
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Gangneung Asan Hospital Gangneung
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul
Korea, Republic of The Catholic University of Korea, Yeouido St. Mary's Hospital Seoul
Korea, Republic of St.carollo Hospital Suncheon
Korea, Republic of Wonju Severance Christian Hospital Wonju

Sponsors (2)
Lead Sponsor Collaborator
Seung-Jung Park CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) 1 year
Secondary All cause death 5 year
Secondary Cardiac death 5 year
Secondary Myocardial Infarction 5 year
Secondary Composite event rate of death or myocardial infarction (MI) 5 year
Secondary Composite event rate of cardiac death or myocardial infarction (MI) 5 year
Secondary Target- Vessel Revascularization 5 year
Secondary Target- Lesion Revascularization 5 year
Secondary Stent thrombosis 5 year
Secondary Stroke 5 year
Secondary Procedural Success rate Procedural success rate is defined as < 30 % final stenosis and the absence of in-hospital event including death, myocardial infarction, repeat revascularization. 5 year
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