Status:
COMPLETED
Evaluation of Diabetic Effects on Clinical Outcomes After Sirolimus-Eluting Stents in the AsIAN Population
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
Johnson & Johnson
CardioVascular Research Foundation, Korea
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety and performance of the CYPHER SELECT™+ Sirolimus-eluting Stent (SES) in Asian diabetic patients.
Detailed Description
Study design This is a multi center, prospective, post market surveillance study of diabetic patients who underwent CYPHER SELECT™+ Sirolimus-eluting Coronary Stent implantation. For comparison, non-d...
Eligibility Criteria
Inclusion
- Patients receiving CYPHER SELECT™+ Sirolimus-eluting Coronary Stent
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
Exclusion
- Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, or sirolimus
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
- Cardiogenic shock
- Terminal illness with life expectancy \<1 year
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
953 Patients enrolled
Trial Details
Trial ID
NCT00997711
Start Date
April 1 2009
End Date
June 1 2012
Last Update
November 17 2015
Active Locations (14)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
2
Busan Saint Mary's Hospital
Busan, South Korea
3
Daegu Catholic University Medical Center
Daegu, South Korea
4
Keimyung University Dongsan Medical Center
Daegu, South Korea