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NCT02042300 Clinical Trial

XIENCE Xpedition/Alpine/Sierra in Routine Clinical Practice

Coronary Artery Disease Clinical Trial

— IRIS XPEDITION  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02042300
Other study ID # AMCCV2013-11
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 2014
Est. completion date July 2024

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

Clinical Trial Summary

The purpose of this study is to evaluate effectiveness and safety of XIENCE Xpedition/Alpine/Sierra in Routine Clinical Practice

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 4000
Est. completion date July 2024
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Age 19 and more - Intervention with XIENCE Xpedition or Alpine or Sierra everolimus eluting coronary stent - Agreed with written informed consent form Exclusion Criteria: - Intervention with XIENCE Xpedition or Alpine or Sierra everolimus eluting coronary stent and other drug eluting stent at the same time - Life expectancy of 1year and under - Cardiac shock

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• XIENCE Xpedition/Alpine/Sierra

Locations
Country Name City State
Korea, Republic of Hallym University Sacred Heart Hospital Anyang
Korea, Republic of Soon Chun Hyang University Hospital Bucheon 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 Yeungnam University 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 Gachon University Gil Hospital Incheon
Korea, Republic of Inha University Hospital Incheon
Korea, Republic of ChonBuk National University Hospital Jeonju
Korea, Republic of Kwangju Christian Hospital Kwangju
Korea, Republic of Dong-A Medical Center Pusan
Korea, Republic of Inje University HAEUNDAE Paik Hospital Pusan
Korea, Republic of Inje University Pusan Paik Hospital Pusan
Korea, Republic of Pusan National University Hospital Pusan
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Seoul Veterans Hospital Seoul
Korea, Republic of The Catholic University of Korea Seoul St. Mary's Hospital Seoul
Korea, Republic of The Catholic University of Korea, Yeouido St. Mary's Hospital Seoul
Korea, Republic of The Catholic University of Korea Uijeongbu St. Mary's Hospital Uijeongbu
Korea, Republic of Ulsan University Hospital Ulsan
Korea, Republic of Pusan National University Yangsan Hospital Yangsan

Sponsors (3)
Lead Sponsor Collaborator
Seung-Jung Park Abbott, 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 Death, non fatal myocardial infarction, Target Vessel Revascularization 1year
Secondary All death 5year
Secondary Cardiac death 5year
Secondary Myocardial infarction 5year
Secondary Composite event of death or myocardial infarction 5year
Secondary Composite event of cardiac death or myocardial infarction 5year
Secondary Target Vessel revascularization 5year
Secondary Target lesion revascularization 5year
Secondary Stent thrombosis by an Academic Research Consortium (ARC) criteria 5year
Secondary Stroke 5year
Secondary procedural success defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization
participants will be followed for the duration of hospital stay, an expected average of 3days.		 3day
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