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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01515228
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : January 9, 2015
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Xience Prime Device: Cilotax stent Phase 4

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  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2012
Primary Completion Date : December 2014
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Xience Prime stent
everolimus eluting stent
Device: Cilotax stent
paclitaxel with cilostazol dual drug eluting stent implantation
Other Name: 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 Name: everolimus-eluting stent

Primary Outcome Measures :
  1. In-segment late luminal loss [ Time Frame: at 9 month angiographic follow-up ]

Secondary Outcome Measures :
  1. All Death [ Time Frame: 12 months ]
  2. Cardiac death [ Time Frame: 12 months ]
  3. Myocardial infarction [ Time Frame: 12 months ]
  4. Target vessel revascularization (ischemia-driven) [ Time Frame: 12 months ]
  5. Target lesion revascularization (ischemia-driven) [ Time Frame: 12 months ]
  6. Stent thrombosis (by ARC definition) [ Time Frame: 12 months ]
  7. Binary restenosis in both in-stent and in-segment [ Time Frame: at 9 month angiographic follow-up ]
  8. Angiographic pattern of restenosis [ Time Frame: at 9 month angiographic follow-up ]
  9. Procedural success [ Time Frame: 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

  10. All Death [ Time Frame: 1 month ]
  11. All Death [ Time Frame: 4 months ]
  12. All Death [ Time Frame: 9 months ]
  13. Cardiac death [ Time Frame: 1 month ]
  14. Cardiac death [ Time Frame: 4 months ]
  15. Cardiac death [ Time Frame: 9 months ]
  16. Myocardial infarction [ Time Frame: 1 month ]
  17. Myocardial infarction [ Time Frame: 4 months ]
  18. Myocardial infarction [ Time Frame: 9 months ]
  19. Target vessel revascularization (ischemia-driven) [ Time Frame: 1 month ]
  20. Target vessel revascularization (ischemia-driven) [ Time Frame: 4 months ]
  21. Target vessel revascularization (ischemia-driven) [ Time Frame: 9 months ]
  22. Target lesion revascularization (ischemia-driven) [ Time Frame: 1 month ]
  23. Target lesion revascularization (ischemia-driven) [ Time Frame: 4 months ]
  24. Target lesion revascularization (ischemia-driven) [ Time Frame: 9 months ]
  25. Stent thrombosis (by ARC definition) [ Time Frame: 1 month ]
  26. Stent thrombosis (by ARC definition) [ Time Frame: 4 months ]
  27. Stent thrombosis (by ARC definition) [ Time Frame: 9 months ]

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Ages Eligible for Study:   21 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


  • 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


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01515228

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
Chungnam National University Hospital
Daejeon, Korea, Republic of
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, Korea, Republic of
Gangneung Asan Hospital
Gangneung, Korea, Republic of
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
CardioVascular Research Foundation, Korea
Principal Investigator: Cheol-Whan Lee, MD Asan Medical Center

Responsible Party: CHEOL WHAN LEE, MD, PhD., MD, CardioVascular Research Foundation, Korea Identifier: NCT01515228     History of Changes
Other Study ID Numbers: CVRF2011-11
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by CHEOL WHAN LEE, MD, PhD., CardioVascular Research Foundation, Korea:
requiring drug eluting stents

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents