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Recruiting NCT05981911

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

— Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: XIENCE Skypoint™ stent.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Device XIENCE Skypoint™ stent
    Percutaneous coronary intervention with Xience-Skypoint™ stent

Primary outcome measures

  • the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) [Time frame: 12 months]
Secondary outcome measures (10)
  • the event rate of all cause death [Time frame: 5 years]
  • the event rate of cardiac death [Time frame: 5 years]
  • the event rate of nonfatal myocardial infarction [Time frame: 5 years]
  • the composite event rate of death, or nonfatal myocardial infarction (MI) [Time frame: 5 years]
  • the composite event rate of cardiac death, or nonfatal myocardial infarction (MI) [Time frame: 5 years]
  • the event rate of Target- Vessel Revascularization (TVR) [Time frame: 5 years]
  • the event rate of Target- lesion Revascularization (TLR) [Time frame: 5 years]
  • the event rate of stent thrombosis [Time frame: 5 years]
  • the event rate of stroke [Time frame: 5 years]
  • the event rate of Procedural success [Time frame: 7 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Asan Medical Hospital — Seoul

Identifiers

NCT: NCT05981911 · AMCCV2023-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗