NCT01035450

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,206 (actual)
• Sponsor: Takeshi Morimoto · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Everolimus-eluting stent	Everolimus-eluting stent
DEVICE	Sirolimus-eluting stent	Sirolimus-eluting stent

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-03-01
• Completion: 2014-05-01
• First posted: 2009-12-18
• Last updated: 2015-12-10

Locations

1 site across 1 country: Japan