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

Coronary Artery Disease Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303640
• Other study ID #: C494
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2011
• Last updated: December 9, 2015
• Start date: May 2011
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3235
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Biolimus-eluting stent
Biolimus-eluting stent
• Everolimus-eluting stent
Everolimus-eluting stent

Locations

Country	Name	City	State
Japan	Department of Cardiovascular Medicine, Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Takeshi Morimoto

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target-lesion revascularization	target-lesion revascularization	1-year	No
Primary	death or myocardial infarction at 3-year after stent implantation	death or myocardial infarction at 3-year after stent implantation	3-year	Yes
Secondary	all-cause death	death due to any cause	3-year	Yes
Secondary	cardiac death	death due to cardiac origins	3-year	Yes
Secondary	acute myocardial infarction	acute myocardial infarction	3-year	Yes
Secondary	stent thrombosis	stent thrombosis defined by Academic Reseach Consortium definition	3-year	Yes
Secondary	stroke	stroke excluding transient ischemic attacks	3-year	Yes
Secondary	bleeding complications	bleeding complications defined by GUSTO and TIMI definitions	3-year	Yes
Secondary	success rate for stent deployment	success rate for stent deployment	3-year	No
Secondary	procedure time	procedure time	3-year	No
Secondary	clinically-driven target-lesion revascularization	clinically-driven target-lesion revascularization	3-year	No
Secondary	non-target-lesion revascularization	non-target-lesion revascularization	3-year	No
Secondary	coronary artery bypass grafting	coronary artery bypass grafting	3-year	No
Secondary	target-vessel revascularization	target-vessel revascularization	3-year	No
Secondary	any repeat coronary revascularization	any repeat coronary revascularization	3-year	No
Secondary	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	3-year	Yes
Secondary	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	3-year	Yes