NCT02042300

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Geographic Reach
1 country

26 active sites

Status
completed

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

January 14, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

6.2 years

First QC Date

January 14, 2014

Last Update Submit

December 22, 2025

Conditions

Keywords

XIENCE XpeditionRoutine Clinical PracticeAlpineSierra

Outcome Measures

Primary Outcomes (1)

  • Composite event rate

    Death, non fatal myocardial infarction, Target Vessel Revascularization

    1year

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (1)

IRIS-Xpedition/Alpine/Sierra Cohort

XIENCE Xpedition/Alpine/Sierra

Device: XIENCE Xpedition/Alpine/Sierra

Interventions

IRIS-Xpedition/Alpine/Sierra Cohort

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with XIENCE Xpedition or Alpine or Sierra stent

You may qualify if:

  • Age 19 and more
  • Intervention with XIENCE Xpedition or Alpine or Sierra everolimus eluting coronary stent
  • Agreed with written informed consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Location

Gangwon National Univ. Hospital

Chuncheon, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

The Catholic University of Korea, Daejeon ST. Mary's Hospital

Daejeon, South Korea

Location

Gangneung Asan Hospital

Gangneung, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

ChonBuk National University Hospital

Jeonju, South Korea

Location

Kwangju Christian Hospital

Kwangju, South Korea

Location

Dong-A Medical Center

Pusan, South Korea

Location

Inje University HAEUNDAE Paik Hospital

Pusan, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Seoul Veterans Hospital

Seoul, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Location

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, South Korea

Location

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 22, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2020

Study Completion

August 30, 2024

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

This is not a publicly funded trial.

Locations