Status:
UNKNOWN
Comparison Between Everolimus-eluting Stent (EES) and Sirolimus-eluting Stent (SES) in the Bifurcation Lesion
Lead Sponsor:
Shin Yukuhashi Hospital
Collaborating Sponsors:
Abbott Medical Devices
Cordis US Corp.
Conditions:
Ischemic Heart Disease
Eligibility:
All Genders
20-85 years
Phase:
NA
Brief Summary
In study-1, the purpose of this study is to compare the long-term outcome of provisional stenting between EES and SES deployment. In study-2, it is to prove the following hypothesis " Asymmetrical exp...
Detailed Description
Kissing balloon inflation brings asymmetrical expansion which may lead to a risk of disturbance of endothelialization. We will investigate the following issues. 1. Impact of asymmetric expansion indu...
Eligibility Criteria
Inclusion
- Coronary bifurcation lesion which stenotic lesion exists in the MV and / or in the side branch (SB).
- The lesion is appropriate for the provisional MV stenting.
- The reference diameter is more than 2.5mm in the MV and more than 2.0mm in the SB.
Exclusion
- Left main coronary bifurcation
- Acute myocardial infarction and unstable angina which culprit vessel contains obvious thrombus
- Left ventricular ejection fraction \< 30%
- Shock state
- Inappropriate candidate for the dual antiplatelet therapy, administration of contrast medium and radiation
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01266239
Start Date
July 1 2010
End Date
July 1 2015
Last Update
December 24 2010
Active Locations (5)
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1
Kobe University
Kobe, Japan
2
Hyogo Medical University
Nishinomiya, Japan
3
Toyohashi Heart Center
Toyohashi, Japan
4
Saiseikai Yokohama Eastern Hospital
Yokohama, Japan