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NCT Number: NCT03967158

Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice

The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the "real world" daily practice as compared with other drug-eluting stents.

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This study is active but is not currently recruiting participants.

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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

Dong-A Medical Center, Busan, 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
  • Patient with Xience Sierra Everolimus eluting coronary stent
  • Written consent

Exclusion criteria

  • Intervention with Xience Sierra Everolimus eluting coronary stent and other drug eluting stent at the same time
  • Life-expectancy less than 1 year
  • Cardiac shock

Treatment and study plan

Xience Sierra stent

Device

Percutaneous coronary intervention with Xience Sierra stent

Primary outcomes

  1. Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)

    Time frame: 1 year

Secondary outcomes

  1. All cause death

    Time frame: 5 year

  2. Cardiac death

    Time frame: 5 year

  3. Myocardial Infarction

    Time frame: 5 year

  4. Composite event rate of death or myocardial infarction (MI)

    Time frame: 5 year

  5. Composite event rate of cardiac death or myocardial infarction (MI)

    Time frame: 5 year

  6. Target- Vessel Revascularization

    Time frame: 5 year

  7. Target- Lesion Revascularization

    Time frame: 5 year

  8. Stent thrombosis

    Time frame: 5 year

  9. Stroke

    Time frame: 5 year

  10. Procedural Success rate

    Time frame: 5 year

    Procedural success rate is defined as < 30 % final stenosis and the absence of in-hospital event including death, myocardial infarction, repeat revascularization.

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 XIENCE Sierra in Routine Clinical Practice; A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY

Acronym: IRIS Sierra

Important dates

Study start
2019
Primary completion
2024
Study completion
2028
First posted
May 30, 2019
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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