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

July 28, 2014 updated by: Seung-Jung Park

Randomized Comparison of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Soonchunhyang University Bucheon Hospital
      • Cheonan, Korea, Republic of
        • Soonchunhyang University Cheonan Hospital
      • Chuncheon, Korea, Republic of
        • Kangwon University Hospital
      • Daejeon, Korea, Republic of
        • Daejeon St Mary's Hospital Catholic University
      • GangNeung, Korea, Republic of
        • Gangneung Asan Hospital
      • Jeonju, Korea, Republic of
        • Chonbuk National University Hospital
      • Pusan, Korea, Republic of
        • Pusan National University Yangsan Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Seoul Veterans Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital
    • Gyeong-gi
      • Anyang, Gyeong-gi, Korea, Republic of
        • Hallym University Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Angiographic in-segment late loss
Time Frame: 9-month angiographic follow-up
9-month angiographic follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Death (all-cause and cardiac)
Time Frame: at 12 months
at 12 months
myocardial infarction
Time Frame: at 12 months
at 12 months
stent thrombosis
Time Frame: at 12 months
at 12 months
target-lesion revascularization
Time Frame: at 12 months
at 12 months
target-vessel revascularization
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea

Investigators

  • Principal Investigator: Seung-Jung Park, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

August 19, 2010

First Submitted That Met QC Criteria

August 20, 2010

First Posted (Estimate)

August 23, 2010

Study Record Updates

Last Update Posted (Estimate)

July 29, 2014

Last Update Submitted That Met QC Criteria

July 28, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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