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

Randomized Comparison of Dual Drug-Eluting Cilotax Stent and Everolimus -Eluting Stent Implantation for DE Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Cilotax stent; Device: Xience Prime

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 Type: Interventional
• Enrollment (Actual): 291
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheonan, Korea, Republic of
    • Soon Chun Hyang University Hospital Cheonan
  • Daegu, Korea, Republic of
    • Daegu Catholic University Medical Center
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Daejeon, Korea, Republic of
    • Chungnam national university hospital
  • Gangneung, Korea, Republic of
    • GangNeung Asan Hospital
  • Pusan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Xience Prime stent; everolimus eluting stent	Device: Cilotax stent; paclitaxel with cilostazol dual drug eluting stent implantation; Other Names: paclitaxel with cilostazol dual drug eluting stent
Experimental: Cilotax stent; paclitaxel with cilostazol dual drug eluting stent	Device: Xience Prime; everolimus-eluting stent implantation; Other Names: everolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-segment late luminal loss	at 9 month angiographic follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death		12 months
Myocardial infarction		12 months
Myocardial infarction		9 months
Myocardial infarction		1 month
All Death		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	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	At discharge from the index hospitalization, an expected average of 3 days.
All Death		1 month
All Death		4 months
All Death		9 months
Cardiac death		1 month
Cardiac death		4 months
Cardiac death		9 months
Myocardial infarction		4 months
Target vessel revascularization (ischemia-driven)		1 month
Target vessel revascularization (ischemia-driven)		4 months
Target vessel revascularization (ischemia-driven)		9 months
Target lesion revascularization (ischemia-driven)		1 month
Target lesion revascularization (ischemia-driven)		4 months
Target lesion revascularization (ischemia-driven)		9 months
Stent thrombosis (by ARC definition)		1 month
Stent thrombosis (by ARC definition)		4 months
Stent thrombosis (by ARC definition)		9 months

Collaborators and Investigators

• Sponsor: CHEOL WHAN LEE, MD, PhD.
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Cheol-Whan Lee, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: January 23, 2012
• First Posted (Estimate): January 24, 2012

Study Record Updates

• Last Update Posted (Estimate): January 9, 2015
• Last Update Submitted That Met QC Criteria: January 8, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: requiring drug eluting stents
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Neuroprotective Agents; Protective Agents; Antineoplastic Agents, Phytogenic; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Paclitaxel; Everolimus; Cilostazol
• Other Study ID Numbers: CVRF2011-11