Back to resultsComparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Xience Prime
Cilotax stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring requiring drug eluting stents
Eligibility Criteria
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:
- 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)
- ST-elevation acute myocardial infraction requiring primary stenting
- 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 ≥ 3times normal
- Renal dysfunction, creatinine ≥ 2.0mg/dL
- Contraindication to aspirin, clopidogrel or cilostazol
- Contraindication to Paclitaxel or everolimus
- 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 for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)
Sites / Locations
- Soon Chun Hyang University Hospital Cheonan
- Daegu Catholic University Medical Center
- Keimyung University Dongsan Medical Center
- Chungnam National University Hospital
- The Catholic University of Korea, Daejeon ST. Mary's Hospital
- Gangneung Asan Hospital
- Inje University Pusan Paik Hospital
- Asan Medical Center
- Ulsan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Xience Prime stent
Cilotax stent
Arm Description
everolimus eluting stent
paclitaxel with cilostazol dual drug eluting stent
Outcomes
Primary Outcome Measures
In-segment late luminal loss
Secondary Outcome Measures
All Death
Cardiac death
Myocardial infarction
Target vessel revascularization (ischemia-driven)
Target lesion revascularization (ischemia-driven)
Stent thrombosis (by ARC definition)
Binary restenosis in both in-stent and in-segment
Angiographic pattern of restenosis
Procedural success
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
All Death
All Death
Cardiac death
Cardiac death
Cardiac death
Myocardial infarction
Myocardial infarction
Myocardial infarction
Target vessel revascularization (ischemia-driven)
Target vessel revascularization (ischemia-driven)
Target vessel revascularization (ischemia-driven)
Target lesion revascularization (ischemia-driven)
Target lesion revascularization (ischemia-driven)
Target lesion revascularization (ischemia-driven)
Stent thrombosis (by ARC definition)
Stent thrombosis (by ARC definition)
Stent thrombosis (by ARC definition)
Full Information
NCT ID
NCT01515228
First Posted
January 18, 2012
Last Updated
January 8, 2015
Sponsor
CHEOL WHAN LEE, MD, PhD.
Collaborators
CardioVascular Research Foundation, Korea
1. Study Identification
Unique Protocol Identification Number
NCT01515228
Brief Title
Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)
Official Title
Randomized Comparison of Dual Drug-Eluting Cilotax Stent and Everolimus -Eluting Stent Implantation for DE Novo Coronary Artery DisEase in Patients With DIABETES Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CHEOL WHAN LEE, MD, PhD.
Collaborators
CardioVascular Research Foundation, Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
requiring drug eluting stents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
291 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xience Prime stent
Arm Type
Active Comparator
Arm Description
everolimus eluting stent
Arm Title
Cilotax stent
Arm Type
Experimental
Arm Description
paclitaxel with cilostazol dual drug eluting stent
Intervention Type
Device
Intervention Name(s)
Xience Prime
Other Intervention Name(s)
everolimus-eluting stent
Intervention Description
everolimus-eluting stent implantation
Intervention Type
Device
Intervention Name(s)
Cilotax stent
Other Intervention Name(s)
paclitaxel with cilostazol dual drug eluting stent
Intervention Description
paclitaxel with cilostazol dual drug eluting stent implantation
Primary Outcome Measure Information:
Title
In-segment late luminal loss
Time Frame
at 9 month angiographic follow-up
Secondary Outcome Measure Information:
Title
All Death
Time Frame
12 months
Title
Cardiac death
Time Frame
12 months
Title
Myocardial infarction
Time Frame
12 months
Title
Target vessel revascularization (ischemia-driven)
Time Frame
12 months
Title
Target lesion revascularization (ischemia-driven)
Time Frame
12 months
Title
Stent thrombosis (by ARC definition)
Time Frame
12 months
Title
Binary restenosis in both in-stent and in-segment
Time Frame
at 9 month angiographic follow-up
Title
Angiographic pattern of restenosis
Time Frame
at 9 month angiographic follow-up
Title
Procedural success
Description
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
Time Frame
At discharge from the index hospitalization, an expected average of 3 days.
Title
All Death
Time Frame
1 month
Title
All Death
Time Frame
4 months
Title
All Death
Time Frame
9 months
Title
Cardiac death
Time Frame
1 month
Title
Cardiac death
Time Frame
4 months
Title
Cardiac death
Time Frame
9 months
Title
Myocardial infarction
Time Frame
1 month
Title
Myocardial infarction
Time Frame
4 months
Title
Myocardial infarction
Time Frame
9 months
Title
Target vessel revascularization (ischemia-driven)
Time Frame
1 month
Title
Target vessel revascularization (ischemia-driven)
Time Frame
4 months
Title
Target vessel revascularization (ischemia-driven)
Time Frame
9 months
Title
Target lesion revascularization (ischemia-driven)
Time Frame
1 month
Title
Target lesion revascularization (ischemia-driven)
Time Frame
4 months
Title
Target lesion revascularization (ischemia-driven)
Time Frame
9 months
Title
Stent thrombosis (by ARC definition)
Time Frame
1 month
Title
Stent thrombosis (by ARC definition)
Time Frame
4 months
Title
Stent thrombosis (by ARC definition)
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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)
ST-elevation acute myocardial infraction requiring primary stenting
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 ≥ 3times normal
Renal dysfunction, creatinine ≥ 2.0mg/dL
Contraindication to aspirin, clopidogrel or cilostazol
Contraindication to Paclitaxel or everolimus
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 for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheol-Whan Lee, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soon Chun Hyang University Hospital Cheonan
City
Cheonan
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Daejeon ST. Mary's Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Gangneung Asan Hospital
City
Gangneung
Country
Korea, Republic of
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Asan Medical Center
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 Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)
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