Clinical Trials Directory

Trials / Completed

CompletedNCT00997763

Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus

Randomized Comparison of Everolimus- Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
300 (actual)
Sponsor
Seung-Jung Park · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.

Detailed description

Diabetic patients often present unfavorable coronary anatomy with small and diffusely diseased vessels (1) and exhibit exaggerated neointimal hyperplasia after bare-metal stent (BMS) implantation as compared with nondiabetics (2). Although drug-eluting stent (DES) implantation significantly reduced the neointimal hyperplasia and angiographic restenosis compared to BMS in diabetic patients (3), presence of diabetes mellitus (DM) have been still associated with an increased risk of restenosis and unfavorable clinical outcomes in the era of DES (4,5). Recently, the relative efficacies of sirolimua-eluting stent (SES) and paclitaxel-eluting stent (PES) in patients with DM have been evaluated in randomized and registry studies (6-10). The present study, ESSENCE-DIABETES Study, compare 8-month angiographic and 1-year clinical outcomes in patients with diabetes mellitus treated with sirolimus-eluting stent (CYPHER) or everolimus-eluting stent (XIENCE V)

Conditions

Interventions

TypeNameDescription
DEVICEXIENCE Veverolimus-eluting stent
DEVICECYPHERsirolimus-eluting stent

Timeline

Start date
2008-07-01
Primary completion
2015-08-01
Completion
2015-08-01
First posted
2009-10-19
Last updated
2016-12-13

Locations

18 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT00997763. Inclusion in this directory is not an endorsement.