Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)

CHEOL WHAN LEE, MD, PhD.

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Xience Prime; Device: Cilotax stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01515228

CVRF2011-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 291 patients

Sex: All

Ages: 21 to 74 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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291 participants in 2 patient groups

Xience Prime stent

Active Comparator group

Description:

everolimus eluting stent

Treatment:

Device: Cilotax stent

Cilotax stent

Experimental group

Description:

paclitaxel with cilostazol dual drug eluting stent

Treatment:

Device: Xience Prime