Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments xience v, cypher
Phase phase 4
Sponsor Seung-Jung Park
Collaborator CardioVascular Research Foundation, Korea
Start date July 2008
End date September 2016
Trial size 280 participants
Trial identifier NCT00997763, 2008-0220

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
everolimus-eluting stent
xience v Xience V stent
everolimus-eluting stent
(Active Comparator)
Using Cypher stent
cypher Cypher elect stent
sirolimus-eluting stent

Primary Outcomes

Measure
Angiographic in-segment late loss at angiography
time frame: 8-month

Secondary Outcomes

Measure
All-cause Death
time frame: 12 month
All-cause Death
time frame: 5 year
Cardiac death
time frame: 12 months
Cardiac death
time frame: 5 year
Myocardial infarction
time frame: 12 months
Myocardial infarction
time frame: 5 year
Target vessel revascularization (all and ischemia-driven)
time frame: 12 months
Target lesion revascularization (all and ischemia-driven)
time frame: 5 year
Stent thrombosis by definition of Academic Research Consortium (ARC)
time frame: 12 months
Stent thrombosis by definition of Academic Research Consortium (ARC)
time frame: 5 year
Binary restenosis in both in-stent and in-segment
time frame: 8 months
Angiographic pattern of restenosis
time frame: 8 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diabetic patients with angina and documented ischemia or patients with documented silent ischemia - Patients who are eligible for intracoronary stenting - Age >18 years, <75 ages - De novo lesion - Percent diameter stenosis ≥50% - Reference vessel size ≥ 2.5 mm by visual estimation Exclusion Criteria: - History of bleeding diathesis or coagulopathy - Pregnant state - Known hypersensitivity or contra-indication to contrast agent and heparin - Limited life-expectancy (less than 1 year) - Acute ST elevation myocardial infarction on admission - Characteristics of lesion 1. Left main disease 2. In-stent restenosis 3. Graft vessels - Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3) - Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal - Renal dysfunction, creatinine ≥ 2.0mg/dL - Contraindication to aspirin, clopidogrel or cilostazol - Left ventricular ejection fraction <30% - Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. - Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).

Additional Information

Official title Randomized Comparison of Everolimus- Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus
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)
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by CardioVascular Research Foundation, Korea.