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

NCT ID: NCT01303640

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Keywords

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Coronary stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biolimus-eluting stent

Biolimus-eluting stent

Group Type ACTIVE_COMPARATOR

Biolimus-eluting stent

Intervention Type DEVICE

Biolimus-eluting stent

Everolimus-eluting stent

Everolimus-eluting stent

Group Type ACTIVE_COMPARATOR

Everolimus-eluting stent

Intervention Type DEVICE

Everolimus-eluting stent

Interventions

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Biolimus-eluting stent

Biolimus-eluting stent

Intervention Type DEVICE

Everolimus-eluting stent

Everolimus-eluting stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for percutaneous coronary intervention using drug-eluting stents
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeshi Morimoto

OTHER

Sponsor Role lead

Responsible Party

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Takeshi Morimoto

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Takeshi Kimura, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Locations

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Department of Cardiovascular Medicine, Kyoto University Hospital

Kyoto, Kyoto, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 29628128 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29508236 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26446596 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24687156 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23684673 (View on PubMed)

Other Identifiers

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C494

Identifier Type: -

Identifier Source: org_study_id