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Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)

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:
NCT01515228
First received: January 18, 2012
Last updated: July 28, 2014
Last verified: July 2014

January 18, 2012
July 28, 2014
January 2012
February 2015   (final data collection date for primary outcome measure)
In-segment late luminal loss [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01515228 on ClinicalTrials.gov Archive Site
  • All Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (ischemia-driven) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia-driven) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stent thrombosis (by ARC definition) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Binary restenosis in both in-stent and in-segment [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
  • Angiographic pattern of restenosis [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
  • Procedural success [ Time Frame: At discharge from the index hospitalization, an expected average of 3 days. ] [ Designated as safety issue: No ]
    achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay
  • All Death [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • All Death [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • All Death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (ischemia-driven) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Target vessel revascularization (ischemia-driven) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Target vessel revascularization (ischemia-driven) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia-driven) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia-driven) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia-driven) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Stent thrombosis (by ARC definition) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (by ARC definition) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (by ARC definition) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)
Randomized Comparison of Dual Drug-Eluting Cilotax Stent and Everolimus -Eluting Stent Implantation for DE Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.

Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 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) Cilotax stent vs. b) Xience Prime stent. 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: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Xience Prime
    everolimus-eluting stent implantation
    Other Name: everolimus-eluting stent
  • Device: Cilotax stent
    paclitaxel with cilostazol dual drug eluting stent implantation
    Other Name: paclitaxel with cilostazol dual drug eluting stent
  • Active Comparator: Xience Prime stent
    everolimus eluting stent
    Intervention: Device: Cilotax stent
  • Experimental: Cilotax stent
    paclitaxel with cilostazol dual drug eluting stent
    Intervention: Device: Xience Prime
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
291
July 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

Clinical:

  • Diabetic patients with active treatment (oral agent or insulin)
  • Patients with angina and documented ischemia or patients with documented silent ischemia
  • Patients who are eligible for intracoronary stenting
  • Age > 20 years, < 75 years

Angiographic:

  • De novo lesion
  • Percent diameter stenosis ≥ 50%
  • Reference vessel size ≥ 2.5 mm by visual estimation

Exclusion Criteria:

  1. History of bleeding diathesis or coagulopathy
  2. Pregnant state
  3. Known hypersensitivity or contra-indication to contrast agent and heparin
  4. Limited life-expectancy (less than 1 year)
  5. ST-elevation acute myocardial infraction requiring primary stenting
  6. Characteristics of lesion: left main disease, in-stent restenosis, graft vessels
  7. Hematological disease (Neutropenia < 3000/mm3), Thrombocytopenia < 100,000/mm3)
  8. Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3times normal
  9. Renal dysfunction, creatinine ≥ 2.0mg/dL
  10. Contraindication to aspirin, clopidogrel or cilostazol
  11. Contraindication to Paclitaxel or everolimus
  12. Left ventricular ejection fraction < 30%
  13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
  14. 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 for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)
Both
21 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01515228
CVRF2011-11
Yes
Seung-Jung Park, CardioVascular Research Foundation, Korea
Seung-Jung Park
CardioVascular Research Foundation, Korea
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
CardioVascular Research Foundation, Korea
July 2014

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