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

Primary Purpose

Coronary Artery Disease, Diabetes

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Endeavor Resolute stent
Cypher stent
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary disease, stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hallym University Sacred Heart Hospital
  • Soonchunhyang University Bucheon Hospital
  • Soonchunhyang University Cheonan Hospital
  • Kangwon University Hospital
  • Daejeon St Mary's Hospital Catholic University
  • GangNeung Asan Hospital
  • Chonbuk National University Hospital
  • Pusan National University Yangsan Hospital
  • Asan Medical Center
  • Seoul Veterans Hospital
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endeavor Resolute stent

Cypher stent

Arm Description

zotarolimus-eluting stent

sirolimus-eluting stent

Outcomes

Primary Outcome Measures

Angiographic in-segment late loss

Secondary Outcome Measures

Death (all-cause and cardiac)
myocardial infarction
stent thrombosis
target-lesion revascularization
target-vessel revascularization

Full Information

First Posted
August 19, 2010
Last Updated
July 28, 2014
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01186107
Brief Title
Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients
Acronym
ESSENCE-DM2
Official Title
Randomized Comparison of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Diabetes
Keywords
coronary disease, stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endeavor Resolute stent
Arm Type
Experimental
Arm Description
zotarolimus-eluting stent
Arm Title
Cypher stent
Arm Type
Active Comparator
Arm Description
sirolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
Endeavor Resolute stent
Intervention Description
zotarolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
Cypher stent
Intervention Description
sirolimus-eluting stent
Primary Outcome Measure Information:
Title
Angiographic in-segment late loss
Time Frame
9-month angiographic follow-up
Secondary Outcome Measure Information:
Title
Death (all-cause and cardiac)
Time Frame
at 12 months
Title
myocardial infarction
Time Frame
at 12 months
Title
stent thrombosis
Time Frame
at 12 months
Title
target-lesion revascularization
Time Frame
at 12 months
Title
target-vessel revascularization
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
State/Province
Gyeong-gi
Country
Korea, Republic of
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Soonchunhyang University Cheonan Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Kangwon University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Daejeon St Mary's Hospital Catholic University
City
Daejeon
Country
Korea, Republic of
Facility Name
GangNeung Asan Hospital
City
GangNeung
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Veterans Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients

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