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NCT Number: NCT03588481

IRIS- DESyne X2 in the IRIS-DES Registry

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

Recruiting

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Key information

Conditions

Coronary Stenosis Cardiovascular Diseases Coronary Disease Coronary Occlusion Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hallym Hospital, Incheon, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

DESyne X2

Device

Novolimus-eluting stent

Primary outcomes

  1. Composite event rate

    Time frame: 1year

    Death, non-fatal myocardial infarction, Target Vessel Revascularization

Secondary outcomes

  1. All death

    Time frame: 5years

  2. Cardiac death

    Time frame: 5years

  3. Myocardial infarction

    Time frame: 5years

  4. Composite event of death or myocardial infarction

    Time frame: 5years

  5. Composite event of cardiac death or myocardial infarction

    Time frame: 5years

  6. Target Vessel revascularization

    Time frame: 5years

  7. Target Lesion revascularization

    Time frame: 5years

  8. Stent thrombosis

    Time frame: 5years

    stent thrombosis as classified by an Academic Research Consortium

  9. Stroke

    Time frame: 5years

  10. Procedural success

    Time frame: 3days

    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, RN

CONTACT

[email protected]

82230104728

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

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

Acronym: IRIS DESyne X2

Important dates

Study start
2018
Primary completion
2027
Study completion
2031
First posted
Jul 17, 2018
Registry last updated
Jun 24, 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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