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Completed

NCT Number: NCT01035450

Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial

The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical 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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiology, Kyoto University Hospital

Kyoto, 606-8507, Japan

About this study

Sirolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Everolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in the first quarter of 2010 by the Japanese Ministry of Health, Labor and Welfare. It has recently been reported that everolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 1 year as compared with paclitaxel-eluting stent. However, trial results comparing everolimus-eluting stent with sirolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for percutaneous coronary intervention using drug-eluting stents

Exclusion criteria

  • None

Treatment and study plan

everolimus-eluting stent

Device

Everolimus-eluting stent

Sirolimus-eluting stent

Device

Sirolimus-eluting stent

Primary outcomes

  1. target-lesion revascularization

    Time frame: 1-year

  2. all-cause death or myocardial infarction

    Time frame: 3-year

Secondary outcomes

  1. all-cause death

    Time frame: 3-year

  2. cardiac death

    Time frame: 3-year

  3. myocardial infarction

    Time frame: 3-year

  4. stent thrombosis (Academic Research Consortium definition)

    Time frame: 3-year

  5. ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes

    Time frame: 3-year

  6. bleeding complications (GUSTO and TIMI definition)

    Time frame: 3-year

  7. stent deployment success

    Time frame: at implantation

  8. procedure time

    Time frame: at implantation

  9. clinically-driven target-lesion revascularization

    Time frame: 3-year

  10. non-target-lesion revascularization

    Time frame: 3-year

  11. coronary artery bypass grafting

    Time frame: 3-year

  12. target-vessel revascularization

    Time frame: 3-year

  13. any repeat coronary revascularization

    Time frame: 3-year

  14. composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization

    Time frame: 3-year

  15. composite of all-cause death, any myocardial infarction or any repeat coronary revascularization

    Time frame: 3-year

Sponsors and collaborators

Lead sponsor

Takeshi Morimoto

Other

Registry information

Acronym: RESET

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 18, 2009
Registry last updated
Dec 10, 2015

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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