Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Xience/PromusDevice: Cypher
- Registration Number
- NCT00960648
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the everolimus-eluting stent (EES) and to determine clinical device and procedural success during commercial use of EES in the real world.
The investigators will compare EES (Xience/Promus, prospective arm) with sirolimus-eluting stent (SES, Cypher, retrospective arm).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4000
- The patient agrees to participate in this study by signing the informed consent form.
- Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
- There are no exclusion criteria for this registry.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Xience/Promus Xience/Promus Active prospective registration of patients receiving everolimus eluting stent Cypher Cypher Retrospective historical controls that received sirolimus-eluting stent
- Primary Outcome Measures
Name Time Method Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization) 12 months
- Secondary Outcome Measures
Name Time Method In-stent & In-segment Late Loss 9 months Stent Thrombosis 1 year Target Vessel Failure (composite of cardiac death, MI, and TVR) 12 months Any death, cardiac death, MI, TLR, TVR 1 year Composite rate of cardiac death and any MI 1 year Composite rate of all death and any MI 1 year Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization 1 year Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy 1 year Clinical device and procedural success During the health care facility stay
Trial Locations
- Locations (18)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kwangju Veterans Hospital
🇰🇷Gwangju, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan, Korea, Republic of
Presbyterian Medical Center
🇰🇷Jeonju, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Chonju, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Iksan, Korea, Republic of
Kyung Hee University Medical Center
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Yonsei University Medical Center
🇰🇷Seoul, Korea, Republic of
Gachon Kil Medical Center
🇰🇷Inchon, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
St. Carollo Hospital
🇰🇷Suncheon, Korea, Republic of
Inje University Pusan Paik Hospital
🇰🇷Pusan, Korea, Republic of