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

August 19, 2010
August 7, 2012
August 2010
December 2012   (final data collection date for primary outcome measure)
Angiographic in-segment late loss [ Time Frame: 9-month angiographic follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01186107 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Diabetes
  • Device: Endeavor Resolute stent
    zotarolimus-eluting stent
  • Device: Cypher stent
    sirolimus-eluting stent
  • Experimental: Endeavor Resolute stent
    zotarolimus-eluting stent
    Intervention: Device: Endeavor Resolute stent
  • Active Comparator: Cypher stent
    sirolimus-eluting stent
    Intervention: Device: Cypher stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
260
March 2013
December 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01186107
2009-0220
Yes
Seung-Jung Park, CardioVascular Research Foundation, Korea
Seung-Jung Park
CardioVascular Research Foundation, Korea
Principal Investigator: Seung-Jung Park Asan Medical Center
CardioVascular Research Foundation, Korea
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP