Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Taxus stent
Vision stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Angioplasty, Transluminal, Percutaneous Coronary, Paclitaxel-eluting stent, Vision stent
Eligibility Criteria
Inclusion Criteria:
- Angiographically proved significant stenosis in native coronary artery (> 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study)
- planned target lesion number =< 2
- reference diameter 2.75 - 4.0 mm
- lesions can be fully covered by one 28 mm or shorter stent
Exclusion Criteria:
- unprotected left main coronary disease with more than 50% stenosis or planned left main angioplasty
- ostial target lesion (within 5 mm of ostium)
- angiographic evidence of thrombus within target lesion
- calcified lesions which cannot be successfully predilated
- instent restenosis
- multi-vessel intervention more than 2 lesions
- atherectomy is planned before stenting
- bifurcation lesion that needs side branch ballooning or stenting
- Severe left ventricular dysfunction with echocardiographic ejection fraction less than 30%
- ST-elevation myocardial infarction within the preceding 72 hours
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Taxus stent group
Vision stent group
Outcomes
Primary Outcome Measures
Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization)
Secondary Outcome Measures
MACE and stent thrombosis by the criteria of Academic Research Consortium
Full Information
NCT ID
NCT00852215
First Posted
February 25, 2009
Last Updated
February 25, 2009
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00852215
Brief Title
Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion?
Acronym
COPE
Official Title
Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion? (COPE Study): Long-Term Follow-up Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
5. Study Description
Brief Summary
We sought to evaluate the long-term safety and efficacy of drug-eluting stent in large vessels compared with bare metal stent.
Detailed Description
Drug-eluting stent (DES) has been proved to reduced restenosis rate dramatically compared to bare metal stent (BMS). However, the long-term safety of DES is still uncertain. Recent meta-analysis showed that very late stent thrombosis rate was higher in DES group although overall mortality was similar between 2 groups.
The safety issue of DES was first suggested in the BASKET-LATE study, which compared cobalt chromium alloy BMS (VISION®, Guidant, USA) with sirolimus- or paclitaxel-coated DES. The study showed a significantly higher rate of death or myocardial infarction in the DES group between 7 and 18 month after the procedure (BMS 1.3%, DES 4.9%, p=0.01). Moreover, benefit to reduce target vessel revascularization was not found and there was even the possibility of late harm in patients treated with DES in large native vessels.
We perform a multicenter prospective randomized study comparing paclitaxel-eluting stent with cobalt chromium stent several years, originally to see whether major adverse cardiac event is significantly lower in DES compared to thin-strut BMS in the non-complex lesion subset. In this article, we would like to investigate the 2-year clinical events in DES and BMS groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Angioplasty, Transluminal, Percutaneous Coronary, Paclitaxel-eluting stent, Vision stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Taxus stent group
Arm Title
2
Arm Type
Active Comparator
Arm Description
Vision stent group
Intervention Type
Device
Intervention Name(s)
Taxus stent
Intervention Description
Stenting with Paclitaxel-eluting coronary stent system for coronary lesions with > 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study
Intervention Type
Device
Intervention Name(s)
Vision stent
Intervention Description
Stenting with VISION coronary stent system for coronary lesions with > 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study
Primary Outcome Measure Information:
Title
Major adverse cardiac event (MACE: cardiac death, myocardial infarction, or target vessel revascularization)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
MACE and stent thrombosis by the criteria of Academic Research Consortium
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Angiographically proved significant stenosis in native coronary artery (> 50% diameter stenosis with ischemic symptoms or positive functional study, or > 70% diameter stenosis without ischemic symptoms or positive functional study)
planned target lesion number =< 2
reference diameter 2.75 - 4.0 mm
lesions can be fully covered by one 28 mm or shorter stent
Exclusion Criteria:
unprotected left main coronary disease with more than 50% stenosis or planned left main angioplasty
ostial target lesion (within 5 mm of ostium)
angiographic evidence of thrombus within target lesion
calcified lesions which cannot be successfully predilated
instent restenosis
multi-vessel intervention more than 2 lesions
atherectomy is planned before stenting
bifurcation lesion that needs side branch ballooning or stenting
Severe left ventricular dysfunction with echocardiographic ejection fraction less than 30%
ST-elevation myocardial infarction within the preceding 72 hours
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyeon-Cheol Gwon, MD,PhD
Phone
82-2-3410-3418
Email
hcgwon@skku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Young Bin Song, MD
Phone
82-2-3410-3419
Email
youngbin.song@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeon-Cheol Gwon, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyoen-Cheol Gwon, MD,PhD
Phone
82-2-3410-3418
Email
hcgwon@skku.edu
First Name & Middle Initial & Last Name & Degree
Young Bin Song, MD
Phone
82-2-3410-3419
Email
youngbin.song@gmail.com
12. IPD Sharing Statement
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Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion?
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