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

This study is currently recruiting participants.
Verified August 2012 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01515228
First received: January 18, 2012
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Device: Xience Prime
Device: Cilotax stent
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • In-segment late luminal loss [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (ischemia-driven) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia-driven) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stent thrombosis (by ARC definition) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Binary restenosis in both in-stent and in-segment [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
  • Angiographic pattern of restenosis [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
  • Procedural success [ Time Frame: At discharge from the index hospitalization, an expected average of 3 days. ] [ Designated as safety issue: No ]
    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

  • All Death [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • All Death [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • All Death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (ischemia-driven) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Target vessel revascularization (ischemia-driven) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Target vessel revascularization (ischemia-driven) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia-driven) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia-driven) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia-driven) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Stent thrombosis (by ARC definition) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (by ARC definition) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (by ARC definition) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515228

Contacts
Contact: Seung-Jung Park, MD, PhD 82-2-3010-4812 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD 82-2-3010-3995 dwpark@amc.seoul.kr

Locations
Korea, Republic of
7 Locations Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01515228     History of Changes
Other Study ID Numbers: CVRF2011-11
Study First Received: January 18, 2012
Last Updated: August 7, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by CardioVascular Research Foundation, Korea:
requiring drug eluting stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cilostazol
Everolimus
Sirolimus
 Paclitaxel
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013