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NCT Number: NCT05981911

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Seung-jung Park, MD

CONTACT

[email protected]

Seung-jung Park, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 19 years old
  • Patients receiving Xience-Skypoint™ stents.
  • 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

  • Patients with a mixture of other DESs
  • Terminal illness with life expectancy <1 year
  • Patients with cardiogenic shock

Treatment and study plan

XIENCE Skypoint™ stent

Device

Percutaneous coronary intervention with Xience-Skypoint™ stent

Primary outcomes

  1. 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.

Secondary outcomes

  1. the event rate of all cause death

    Time frame: 5 years

  2. the event rate of cardiac death

    Time frame: 5 years

  3. the event rate of nonfatal myocardial infarction

    Time frame: 5 years

  4. the composite event rate of death, or nonfatal myocardial infarction (MI)

    Time frame: 5 years

  5. the composite event rate of cardiac death, or nonfatal myocardial infarction (MI)

    Time frame: 5 years

  6. the event rate of Target- Vessel Revascularization (TVR)

    Time frame: 5 years

  7. the event rate of Target- lesion Revascularization (TLR)

    Time frame: 5 years

  8. the event rate of stent thrombosis

    Time frame: 5 years

    according to an Academic Research Consortium (ARC) criteria

  9. the event rate of stroke

    Time frame: 5 years

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-hee Ham, Project manager

CONTACT

[email protected]

82230104728

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

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

Acronym: IRIS Skypoint

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2023
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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