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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Xience Prime; Device: Cilotax stent

• Registration Number: NCT01515228
• Lead Sponsor: CHEOL WHAN LEE, MD, PhD.

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-24
• Primary Completion: 2014-12
• Status Verified: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-08
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cilotax stent	Xience Prime	paclitaxel with cilostazol dual drug eluting stent
Xience Prime stent	Cilotax stent	everolimus eluting stent

Primary Outcome Measures

Name	Time	Method
In-segment late luminal loss	at 9 month angiographic follow-up

Secondary Outcome Measures

Name	Time	Method
All Death	9 months
Stent thrombosis (by ARC definition)	9 months
Cardiac death	9 months
Target vessel revascularization (ischemia-driven)	9 months
Target lesion revascularization (ischemia-driven)	9 months
Myocardial infarction	9 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

Trial Locations

Locations (9)

Gangneung Asan Hospital; 🇰🇷 Gangneung, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Inje University Pusan Paik Hospital; 🇰🇷 Pusan, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

The Catholic University of Korea, Daejeon ST. Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

Soon Chun Hyang University Hospital Cheonan; 🇰🇷 Cheonan, Korea, Republic of

Daegu Catholic University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of