Coronary Artery Disease
Conditions
Keywords
requiring drug eluting stents
Brief summary
The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.
Detailed description
Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Cilotax stent vs. b) Xience Prime stent. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.
Interventions
DEVICEXience Prime
everolimus-eluting stent implantation
DEVICECilotax stent
paclitaxel with cilostazol dual drug eluting stent implantation
Sponsors
CardioVascular Research Foundation, Korea
CHEOL WHAN LEE, MD, PhD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
Clinical: * Diabetic patients with active treatment (oral agent or insulin) * Patients with angina and documented ischemia or patients with documented silent ischemia * Patients who are eligible for intracoronary stenting * Age \> 20 years, \< 75 years Angiographic: * De novo lesion * Percent diameter stenosis ≥ 50% * Reference vessel size ≥ 2.5 mm by visual estimation
Exclusion criteria
1. History of bleeding diathesis or coagulopathy 2. Pregnant state 3. Known hypersensitivity or contra-indication to contrast agent and heparin 4. Limited life-expectancy (less than 1 year) 5. ST-elevation acute myocardial infraction requiring primary stenting 6. Characteristics of lesion: left main disease, in-stent restenosis, graft vessels 7. Hematological disease (Neutropenia \< 3000/mm3), Thrombocytopenia \< 100,000/mm3) 8. Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3times normal 9. Renal dysfunction, creatinine ≥ 2.0mg/dL 10. Contraindication to aspirin, clopidogrel or cilostazol 11. Contraindication to Paclitaxel or everolimus 12. Left ventricular ejection fraction \< 30% 13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period 14. 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 for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment late luminal loss | at 9 month angiographic follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Death | 12 months | — |
| Cardiac death | 12 months | — |
| Myocardial infarction | 12 months | — |
| Target vessel revascularization (ischemia-driven) | 12 months | — |
| Target lesion revascularization (ischemia-driven) | 12 months | — |
| Stent thrombosis (by ARC definition) | 12 months | — |
| Binary restenosis in both in-stent and in-segment | at 9 month angiographic follow-up | — |
| Angiographic pattern of restenosis | at 9 month angiographic follow-up | — |
| Procedural success | At discharge from the index hospitalization, an expected average of 3 days. | achievement of a final diameter stenosis of \<30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay |
Countries
South Korea
Outcome results
None listed