XIENCE Xpedition/Alpine/Sierra in Routine Clinical Practice (IRIS XPEDITION)

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Percutaneous Transluminal Coronary Angioplasty
• Intervention / Treatment: Device: XIENCE Xpedition/Alpine/Sierra

• Study Type: Observational
• Enrollment (Actual): 4000

Contacts and Locations

Study Locations

• South Korea
  • Anyang, South Korea
    • Hallym University Sacred Heart Hospital
  • Bucheon-si, South Korea
    • Soon Chun Hyang University Hospital Bucheon
  • Cheonan, South Korea
    • Soon Chun Hyang University Hospital Cheonan
  • Chuncheon, South Korea
    • Gangwon National Univ. Hospital
  • Daegu, South Korea
    • Keimyung University Dongsan Medical Center
  • Daegu, South Korea
    • Daegu Catholic University Medical Center
  • Daegu, South Korea
    • Yeungnam University Medical Center
  • Daejeon, South Korea
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Gangneung, South Korea
    • GangNeung Asan Hospital
  • Gwangju, South Korea
    • Chonnam National University Hospital
  • Incheon, South Korea
    • Inha University Hospital
  • Incheon, South Korea
    • Gachon University Gil Hospital
  • Jeonju, South Korea
    • Chonbuk National University Hospital
  • Kwangju, South Korea
    • Kwangju Christian hospital
  • Pusan, South Korea
    • Inje University Pusan Paik Hospital
  • Pusan, South Korea
    • Pusan National University Hospital
  • Pusan, South Korea
    • Dong-A Medical Center
  • Pusan, South Korea
    • Inje University Haeundae Paik Hospital
  • Seoul, South Korea
    • Asan Medical Center
  • Seoul, South Korea
    • Korea University Guro Hospital
  • Seoul, South Korea
    • The Catholic University of Korea Seoul St. Mary's Hospital
  • Seoul, South Korea
    • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • Seoul, South Korea
    • Seoul Veterans Hospital
  • Uijeongbu-si, South Korea
    • The Catholic University of Korea Uijeongbu St. Mary's Hospital
  • Ulsan, South Korea
    • Ulsan University Hospital
  • Yangsan, South Korea
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with XIENCE Xpedition or Alpine or Sierra stent

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IRIS-Xpedition/Alpine/Sierra Cohort; XIENCE Xpedition/Alpine/Sierra	Device: XIENCE Xpedition/Alpine/Sierra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite event rate	Death, non fatal myocardial infarction, Target Vessel Revascularization	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All death		5year
Cardiac death		5year
Myocardial infarction		5year
Composite event of death or myocardial infarction		5year
Composite event of cardiac death or myocardial infarction		5year
Target Vessel revascularization		5year
Target lesion revascularization		5year
Stent thrombosis by an Academic Research Consortium (ARC) criteria		5year
Stroke		5year
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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: Abbott; CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: January 19, 2014
• First Posted (Estimated): January 22, 2014

Study Record Updates

• Last Update Posted (Estimated): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Routine Clinical Practice; XIENCE Xpedition; Alpine; Sierra
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: AMCCV2013-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.