Menu
Recruiting NCT03588481

IRIS- DESyne X2 in the IRIS-DES Registry

— Observational Coronary Stenosis Coronary Occlusion Coronary 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: DESyne X2.
Who it may be relevant to
Registry conditions: Coronary Stenosis, Coronary Occlusion, Coronary 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

Evaluation of Effectiveness and Safety of DESyne X2 in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Overview

This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.

Interventions

  • Device DESyne X2
    Novolimus-eluting stent

Primary outcome measures

  • Composite event rate [Time frame: 1year]
Secondary outcome measures (10)
  • All death [Time frame: 5years]
  • Cardiac death [Time frame: 5years]
  • Myocardial infarction [Time frame: 5years]
  • Composite event of death or myocardial infarction [Time frame: 5years]
  • Composite event of cardiac death or myocardial infarction [Time frame: 5years]
  • Target Vessel revascularization [Time frame: 5years]
  • Target Lesion revascularization [Time frame: 5years]
  • Stent thrombosis [Time frame: 5years]
  • Stroke [Time frame: 5years]
  • Procedural success [Time frame: 3days]

Eligibility criteria

Inclusion criteria

  • Age 19 and more
  • Intervention with DeSyne X2 drug-eluting coronary stent
  • Agreed with written informed consent form

Exclusion criteria

  • Intervention with DeSyne X2 drug-eluting coronary stent and other drug eluting stent at the same time
  • Life expectancy of 1year and under
  • Cardiac 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 · 6 centers
  • Hallym Hospital — Incheon
  • Asan Medical Hospital — Seoul
  • Korea University Guro Hospital — Seoul
  • The Catholic University of Korea Seoul St. Mary's Hospital — Seoul
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul
  • St.carollo Hospital — Suncheon

Identifiers

NCT: NCT03588481 · AMCCV2018-09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗