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Completed

NCT Number: NCT01303640

NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial

The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-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

Department of Cardiovascular Medicine, Kyoto University Hospital

Kyoto, 606-8507, Japan

About this study

Everolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Biolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in 2011 by the Japanese Ministry of Health, Labor and Welfare. It has been reported that biolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 9 months as compared with paclitaxel-eluting stent. However, trial results comparing biolimus-eluting stent with everolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-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

Treatment and study plan

Biolimus-eluting stent

Device

Biolimus-eluting stent

everolimus-eluting stent

Device

Everolimus-eluting stent

Primary outcomes

  1. target-lesion revascularization

    Time frame: 1-year

    target-lesion revascularization

  2. death or myocardial infarction at 3-year after stent implantation

    Time frame: 3-year

    death or myocardial infarction at 3-year after stent implantation

Secondary outcomes

  1. all-cause death

    Time frame: 3-year

    death due to any cause

  2. cardiac death

    Time frame: 3-year

    death due to cardiac origins

  3. acute myocardial infarction

    Time frame: 3-year

    acute myocardial infarction

  4. stent thrombosis

    Time frame: 3-year

    stent thrombosis defined by Academic Reseach Consortium definition

  5. stroke

    Time frame: 3-year

    stroke excluding transient ischemic attacks

  6. bleeding complications

    Time frame: 3-year

    bleeding complications defined by GUSTO and TIMI definitions

  7. success rate for stent deployment

    Time frame: 3-year

    success rate for stent deployment

  8. procedure time

    Time frame: 3-year

    procedure time

  9. clinically-driven target-lesion revascularization

    Time frame: 3-year

    clinically-driven target-lesion revascularization

  10. non-target-lesion revascularization

    Time frame: 3-year

    non-target-lesion revascularization

  11. coronary artery bypass grafting

    Time frame: 3-year

    coronary artery bypass grafting

  12. target-vessel revascularization

    Time frame: 3-year

    target-vessel revascularization

  13. any repeat coronary revascularization

    Time frame: 3-year

    any repeat coronary revascularization

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

    Time frame: 3-year

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

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

    Time frame: 3-year

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

Sponsors and collaborators

Lead sponsor

Takeshi Morimoto

Other

Registry information

Acronym: NEXT

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 25, 2011
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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