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Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients (ESSENCE-DM2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01186107
First received: August 19, 2010
Last updated: August 7, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.


Condition Intervention Phase
Coronary Artery Disease
Diabetes
 Device: Endeavor Resolute stent
Device: Cypher stent
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Comparison of Zotarolimus-Eluting Stent Versus Sirolimus-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:
  • Angiographic in-segment late loss [ Time Frame: 9-month angiographic follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death (all-cause and cardiac) [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • target-lesion revascularization [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • target-vessel revascularization [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Enrollment: 260
Study Start Date: August 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endeavor Resolute stent
zotarolimus-eluting stent
 Device: Endeavor Resolute stent
zotarolimus-eluting stent
Active Comparator: Cypher stent
sirolimus-eluting stent
 Device: Cypher stent
sirolimus-eluting stent

Detailed Description:

Prospective, two arms, single blind, randomized multi-center trial of 380 patients enrolled at 24 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) Endeavor Resolute stent vs. b) Cypher select. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic patients with angina and documented ischemia
  • Patients who are eligible for intracoronary stenting
  • De novo lesion
  • Percent diameter stenosis ≥50%
  • Reference vessel size ≥ 2.5 mm by visual estimation

Exclusion Criteria:

  • History of bleeding diathesis or coagulopathy
  • Pregnant state
  • Known hypersensitivity or contra-indication to contrast agent and heparin
  • Limited life-expectancy (less than 1 year)
  • Acute ST elevation myocardial infarction on admission
  • Characteristics of lesion Left main disease In-stent restenosis Graft vessels
  • Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)
  • Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal
  • Renal dysfunction, creatinine ≥ 2.0mg/dL
  • Contraindication to aspirin, clopidogrel or cilostazol
  • Left ventricular ejection fraction <30%
  • Patients who are actively participating in another drug or device - investigational study, which have not completed the primary endpoint follow- up period.
  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186107

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Gyeong-gi, Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Soonchunhyang University Cheonan Hospital
Cheonan, Korea, Republic of
Kangwon University Hospital
Chuncheon, Korea, Republic of
Daejeon St Mary's Hospital Catholic University
Daejeon, Korea, Republic of
GangNeung Asan Hospital
GangNeung, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of
Pusan National University Yangsan Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Seoul Veterans Hospital
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park Asan Medical Center
  More Information

No publications provided

Responsible Party: Seung-Jung Park, M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01186107     History of Changes
Other Study ID Numbers: 2009-0220
Study First Received: August 19, 2010
Last Updated: August 7, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
coronary disease
stent

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
 Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 18, 2013