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CompletedNCT01303640NEXTUpdated Dec 10, 2015

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

A Phase 4 interventional study of Biolimus-eluting stent and Everolimus-eluting stent in Coronary Artery Disease, sponsored by Takeshi Morimoto. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2015-12-10.

Sponsored by Takeshi Morimoto · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
3,235
Allocation
Randomized
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary stent
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 3,235 is above the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Takeshi Morimoto is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Patients scheduled for percutaneous coronary intervention using drug-eluting stents
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,235 participants (actual)

Study arms

  • Active comparator
    Biolimus-eluting stent

    Biolimus-eluting stent

    Device: Biolimus-eluting stent

  • Active comparator
    Everolimus-eluting stent

    Everolimus-eluting stent

    Device: Everolimus-eluting stent

Interventions

  • DeviceBiolimus-eluting stent

    Biolimus-eluting stent

  • DeviceEverolimus-eluting stent

    Everolimus-eluting stent

06

What researchers measure

Primary outcomes

  1. target-lesion revascularization

    target-lesion revascularization

    Time frame: 1-year

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

    death or myocardial infarction at 3-year after stent implantation

    Time frame: 3-year

Secondary outcomes

  1. all-cause death

    death due to any cause

    Time frame: 3-year

  2. cardiac death

    death due to cardiac origins

    Time frame: 3-year

  3. acute myocardial infarction

    acute myocardial infarction

    Time frame: 3-year

  4. stent thrombosis

    stent thrombosis defined by Academic Reseach Consortium definition

    Time frame: 3-year

  5. stroke

    stroke excluding transient ischemic attacks

    Time frame: 3-year

  6. bleeding complications

    bleeding complications defined by GUSTO and TIMI definitions

    Time frame: 3-year

  7. success rate for stent deployment

    success rate for stent deployment

    Time frame: 3-year

  8. procedure time

    procedure time

    Time frame: 3-year

  9. clinically-driven target-lesion revascularization

    clinically-driven target-lesion revascularization

    Time frame: 3-year

  10. non-target-lesion revascularization

    non-target-lesion revascularization

    Time frame: 3-year

  11. coronary artery bypass grafting

    coronary artery bypass grafting

    Time frame: 3-year

  12. target-vessel revascularization

    target-vessel revascularization

    Time frame: 3-year

  13. any repeat coronary revascularization

    any repeat coronary revascularization

    Time frame: 3-year

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

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

    Time frame: 3-year

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

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

    Time frame: 3-year

07

Study locations

1 site
  • Department of Cardiovascular Medicine, Kyoto University Hospital
    Kyoto, 606-8507, Japan
08

References and documents

Publications

  • Ito S, Watanabe H, Morimoto T, Yoshikawa Y, Shiomi H, Shizuta S, Ono K, Yamaji K, Soga Y, Hyodo M, Shirai S, Ando K, Horiuchi H, Kimura T. Impact of Baseline Thrombocytopenia on Bleeding and Mortality After Percutaneous Coronary Intervention. Am J Cardiol. 2018 Jun 1;121(11):1304-1314. doi: 10.1016/j.amjcard.2018.02.010. Epub 2018 Mar 1. PubMed 29628128 ↗
  • Watanabe H, Morimoto T, Shiomi H, Yoshikawa Y, Kato T, Saito N, Shizuta S, Ono K, Yamaji K, Ando K, Kaji S, Furukawa Y, Akao M, Ishikawa T, Tamura T, Yamamoto Y, Muramatsu T, Suwa S, Nakagawa Y, Kadota K, Takatsu Y, Nishikawa H, Hiasa Y, Hayashi Y, Miyazaki S, Kimura T. Mortality impact of post-discharge myocardial infarction size after percutaneous coronary intervention: a patient-level pooled analysis from the 4 large-scale Japanese studies. Cardiovasc Interv Ther. 2019 Jan;34(1):47-58. doi: 10.1007/s12928-018-0517-x. Epub 2018 Mar 5. PubMed 29508236 ↗
  • Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T. Final 3-Year Outcome of a Randomized Trial Comparing Second-Generation Drug-Eluting Stents Using Either Biodegradable Polymer or Durable Polymer: NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial. Circ Cardiovasc Interv. 2015 Oct;8(10):e002817. doi: 10.1161/CIRCINTERVENTIONS.115.002817. PubMed 26446596 ↗
  • Natsuaki M, Kozuma K, Morimoto T, Shiomi H, Kimura T. Two-year outcome of a randomized trial comparing second-generation drug-eluting stents using biodegradable or durable polymer. JAMA. 2014 May;311(20):2125-7. doi: 10.1001/jama.2014.3584. No abstract available. PubMed 24687156 ↗
  • Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T; NEXT Investigators. Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: a randomized, controlled, noninferiority trial. J Am Coll Cardiol. 2013 Jul 16;62(3):181-190. doi: 10.1016/j.jacc.2013.04.045. Epub 2013 May 15. PubMed 23684673 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01303640
Lead sponsor
Takeshi Morimoto
Responsible party
Takeshi Morimoto (Professor, Kyoto University, Graduate School of Medicine) — Sponsor-investigator
First posted
Feb 25, 2011
Start date
May 2011
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Dec 10, 2015

Study contacts

Takeshi Kimura, MD, PhD
principal investigator · Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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