Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice (IRIS Sierra)

December 28, 2025 updated by: Seung-Jung Park

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Busan, South Korea
        • Inje University Busan Paik Hospital
      • Busan, South Korea
        • Dong-A Medical Center
      • Chuncheon, South Korea
        • Gangwon National Univ. Hospital
      • Daegu, South Korea
        • Keimyung University Dongsan Medical Center
      • Gangneung, South Korea
        • GangNeung Asan Hospital
      • Seoul, South Korea
        • Asan Medical Center
      • Seoul, South Korea
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Seoul, South Korea
        • The Catholic University of Korea, Yeouido St. Mary's Hospital
      • Suncheon, South Korea
        • St.carollo Hospital
      • Wŏnju, South Korea
        • WonJu Severance Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patient with Xience Sierra coronary stent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Consecutive percutaneous coronary intervention
Device: Xience Sierra stent
Percutaneous coronary intervention with Xience Sierra stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2019

Primary Completion (Actual)

August 27, 2024

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

May 27, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV2019-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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