Clinical trial NCT01515228: Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)
Official title: Randomized Comparison of Dual Drug-Eluting Cilotax Stent and Everolimus -Eluting Stent Implantation for DE Novo Coronary Artery DisEase in Patients With DIABETES Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: requiring drug eluting stents
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2012-01-24
Enrollment: 291
Sex: ALL
Minimum age (years): 21
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: In-segment late luminal loss
timeFrame: at 9 month angiographic follow-up
Secondary outcomes:
measure: All Death
timeFrame: 12 months
measure: Cardiac death
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 12 months
measure: Target vessel revascularization (ischemia-driven)
timeFrame: 12 months
measure: Target lesion revascularization (ischemia-driven)
timeFrame: 12 months
measure: Stent thrombosis (by ARC definition)
timeFrame: 12 months
measure: Binary restenosis in both in-stent and in-segment
timeFrame: at 9 month angiographic follow-up
measure: Angiographic pattern of restenosis
timeFrame: at 9 month angiographic follow-up
measure: Procedural success
timeFrame: At discharge from the index hospitalization, an expected average of 3 days.
measure: All Death
timeFrame: 1 month
measure: All Death
timeFrame: 4 months
measure: All Death
timeFrame: 9 months
measure: Cardiac death
timeFrame: 1 month
measure: Cardiac death
timeFrame: 4 months
measure: Cardiac death
timeFrame: 9 months
measure: Myocardial infarction
timeFrame: 1 month
measure: Myocardial infarction
timeFrame: 4 months
measure: Myocardial infarction
timeFrame: 9 months
measure: Target vessel revascularization (ischemia-driven)
timeFrame: 1 month
measure: Target vessel revascularization (ischemia-driven)
timeFrame: 4 months
measure: Target vessel revascularization (ischemia-driven)
timeFrame: 9 months
measure: Target lesion revascularization (ischemia-driven)
timeFrame: 1 month
measure: Target lesion revascularization (ischemia-driven)
timeFrame: 4 months
measure: Target lesion revascularization (ischemia-driven)
timeFrame: 9 months
measure: Stent thrombosis (by ARC definition)
timeFrame: 1 month
measure: Stent thrombosis (by ARC definition)
timeFrame: 4 months
measure: Stent thrombosis (by ARC definition)
timeFrame: 9 months
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST. Mary's Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Asan Medical Center
name: Cheol-Whan Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: