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Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus (ESSENCE-DM)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
XIENCE V
CYPHER
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 stenting, XIENCE V, CYPHER

Eligibility Criteria

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

Inclusion Criteria:

  • Diabetic patients with angina and documented ischemia or patients with documented silent ischemia
  • Patients who are eligible for intracoronary stenting
  • Age >18 years, <75 ages
  • 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

    1. Left main disease
    2. In-stent restenosis
    3. 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

  • Soonchunhyang University Bucheon Hospital
  • Busan Saint Mary's Hospital
  • Soonchunhyang University Cheonan Hospital
  • Cheongju Saint Mary's Hospital
  • Kangwon University Hospital
  • Chungnam National University Hospital
  • Daejeon St Mary's Hospital Catholic University
  • Asan Medical Center
  • Chonbuk National University Hospital
  • Kyungsang University Hospital
  • Inje University Pusan Paik Hospital
  • Pusan Natioanal University Hospital
  • Hallym University Sacred Heart Hospital
  • Asan Medical Center
  • Hallym University Sacred Heart Hospital
  • Korea Veterans Hospital
  • Soonchunhyang University Seoul Hospital
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

XIENCE V

CYPHER

Arm Description

everolimus-eluting stent

Using Cypher stent

Outcomes

Primary Outcome Measures

Angiographic in-segment late loss at angiography

Secondary Outcome Measures

All-cause Death
All-cause Death
Cardiac death
Cardiac death
Myocardial infarction
Myocardial infarction
Target vessel revascularization (all and ischemia-driven)
Target lesion revascularization (all and ischemia-driven)
Stent thrombosis by definition of Academic Research Consortium (ARC)
Stent thrombosis by definition of Academic Research Consortium (ARC)
Binary restenosis in both in-stent and in-segment
Angiographic pattern of restenosis

Full Information

First Posted
October 18, 2009
Last Updated
December 12, 2016
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00997763
Brief Title
Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus
Acronym
ESSENCE-DM
Official Title
Randomized Comparison of Everolimus- 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
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (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 Everolimus- Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.
Detailed Description
Diabetic patients often present unfavorable coronary anatomy with small and diffusely diseased vessels (1) and exhibit exaggerated neointimal hyperplasia after bare-metal stent (BMS) implantation as compared with nondiabetics (2). Although drug-eluting stent (DES) implantation significantly reduced the neointimal hyperplasia and angiographic restenosis compared to BMS in diabetic patients (3), presence of diabetes mellitus (DM) have been still associated with an increased risk of restenosis and unfavorable clinical outcomes in the era of DES (4,5). Recently, the relative efficacies of sirolimua-eluting stent (SES) and paclitaxel-eluting stent (PES) in patients with DM have been evaluated in randomized and registry studies (6-10). The present study, ESSENCE-DIABETES Study, compare 8-month angiographic and 1-year clinical outcomes in patients with diabetes mellitus treated with sirolimus-eluting stent (CYPHER) or everolimus-eluting stent (XIENCE V)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
stenting, XIENCE V, CYPHER

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
XIENCE V
Arm Type
Active Comparator
Arm Description
everolimus-eluting stent
Arm Title
CYPHER
Arm Type
Active Comparator
Arm Description
Using Cypher stent
Intervention Type
Device
Intervention Name(s)
XIENCE V
Other Intervention Name(s)
Xience V stent
Intervention Description
everolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
CYPHER
Other Intervention Name(s)
Cypher elect stent
Intervention Description
sirolimus-eluting stent
Primary Outcome Measure Information:
Title
Angiographic in-segment late loss at angiography
Time Frame
8-month
Secondary Outcome Measure Information:
Title
All-cause Death
Time Frame
12 month
Title
All-cause Death
Time Frame
5 year
Title
Cardiac death
Time Frame
12 months
Title
Cardiac death
Time Frame
5 year
Title
Myocardial infarction
Time Frame
12 months
Title
Myocardial infarction
Time Frame
5 year
Title
Target vessel revascularization (all and ischemia-driven)
Time Frame
12 months
Title
Target lesion revascularization (all and ischemia-driven)
Time Frame
5 year
Title
Stent thrombosis by definition of Academic Research Consortium (ARC)
Time Frame
12 months
Title
Stent thrombosis by definition of Academic Research Consortium (ARC)
Time Frame
5 year
Title
Binary restenosis in both in-stent and in-segment
Time Frame
8 months
Title
Angiographic pattern of restenosis
Time Frame
8 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 or patients with documented silent ischemia Patients who are eligible for intracoronary stenting Age >18 years, <75 ages 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).
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Busan Saint Mary's Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Soonchunhyang University Cheonan Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Cheongju Saint Mary's Hospital
City
Cheongju
Country
Korea, Republic of
Facility Name
Kangwon University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Daejeon St Mary's Hospital Catholic University
City
Daejeon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
GangNeung
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Kyungsang University Hospital
City
Jinju
Country
Korea, Republic of
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Pusan Natioanal University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
PyeongChon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea Veterans Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Soonchunhyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is not a publicly funded trial.

Learn more about this trial

Comparison of Everolimus-Eluting Stent vs Sirolimus-Eluting Stent in Patients With DIABETES Mellitus

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