Status:
UNKNOWN
Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion?
Lead Sponsor:
Samsung Medical Center
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 showe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00852215
Start Date
August 1 2008
End Date
July 1 2010
Last Update
February 26 2009
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710