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

Active, not recruiting

• Conditions: Coronary Artery Disease; Coronary Disease
• Interventions: Device: Xience Sierra stent

• Registration Number: NCT03967158
• Lead Sponsor: Seung-Jung Park

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Study Start: 2019-12-23
• Primary Completion: 2024-08-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Age 19 and more
• Patient with Xience Sierra Everolimus eluting coronary stent
• Written consent

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Consecutive percutaneous coronary intervention	Xience Sierra stent	-

Primary Outcome Measures

Name	Time	Method
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)	1 year

Secondary Outcome Measures

Name	Time	Method
Cardiac death	5 year
Target- Vessel Revascularization	5 year
Composite event rate of cardiac death or myocardial infarction (MI)	5 year
Target- Lesion Revascularization	5 year
All cause death	5 year
Myocardial Infarction	5 year
Stent thrombosis	5 year
Stroke	5 year
Procedural Success rate	5 year	Procedural success rate is defined as \< 30 % final stenosis and the absence of in-hospital event including death, myocardial infarction, repeat revascularization.
Composite event rate of death or myocardial infarction (MI)	5 year

Trial Locations

Locations (10)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Dong-A Medical Center; 🇰🇷 Busan, Korea, Republic of

The Catholic University of Korea, Yeouido St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Gangwon National Univ. Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Gangneung Asan Hospital; 🇰🇷 Gangneung, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

St.carollo Hospital; 🇰🇷 Suncheon, Korea, Republic of

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

The Catholic University of Korea, Eunpyeong St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of