Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial (RESET)

T

Takeshi Morimoto

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease

Treatments

Device: Sirolimus-eluting stent
Device: Everolimus-eluting stent

Study type

Interventional

Funder types

Other

Identifiers

NCT01035450
C338

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,206 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients scheduled for percutaneous coronary intervention using drug-eluting stents

Exclusion criteria

None

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3,206 participants in 2 patient groups

Everolimus-eluting stent
Experimental group
Treatment:
Device: Everolimus-eluting stent
Sirolimus-eluting stent
Active Comparator group
Treatment:
Device: Sirolimus-eluting stent

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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