Evaluation of Effectiveness and Safety of Xience Skypoint Stents in Routine Clinical Practice (IRIS Skypoint)

December 28, 2025 updated by: Seung-Jung Park

a Non-randomized, Prospective, Open-label Registry to Compare the Effectiveness and Safety of XIENCE Skypoint™ Stents Versus Other DESs in Patients With Coronary Artery Disease

The objective of this study is to evaluate the effectiveness and safety of XIENCE Skypoint stents in comparison to other drug-eluting stents (DES) in real-world practice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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 Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Hospital
        • Contact:
        • Principal Investigator:
          • Seung-jung Park, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients receiving Xience-Skypoint™ stents.

Description

Inclusion Criteria:

  1. Patients ≥ 19 years old
  2. Patients receiving Xience-Skypoint™ stents.
  3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

  1. Patients with a mixture of other DESs
  2. Terminal illness with life expectancy <1 year
  3. Patients with cardiogenic 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
XIENCE Skypoint™ stent
Patients receiving Xience-Skypoint™ stents
Device: XIENCE Skypoint™ stent
Percutaneous coronary intervention with Xience-Skypoint™ stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Time Frame: 12 months

the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure.

A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the event rate of all cause death
Time Frame: 5 years
5 years
the event rate of cardiac death
Time Frame: 5 years
5 years
the event rate of nonfatal myocardial infarction
Time Frame: 5 years
5 years
the composite event rate of death, or nonfatal myocardial infarction (MI)
Time Frame: 5 years
5 years
the composite event rate of cardiac death, or nonfatal myocardial infarction (MI)
Time Frame: 5 years
5 years
the event rate of Target- Vessel Revascularization (TVR)
Time Frame: 5 years
5 years
the event rate of Target- lesion Revascularization (TLR)
Time Frame: 5 years
5 years
the event rate of stent thrombosis
Time Frame: 5 years
according to an Academic Research Consortium (ARC) criteria
5 years
the event rate of stroke
Time Frame: 5 years
5 years
the event rate of Procedural success
Time Frame: 7 days
(defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.
7 days

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 14, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 8, 2023

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

  • AMCCV2023-04

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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