Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Endeavor Resolute stentsDevice: Endeavor Sprint stent
- Registration Number
- NCT00960908
- 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 zotarolimus eluting stent (ZES) and to determine clinical device and procedural success during commercial use of ZES.
The investigators will compare 2nd generation ZE (Endeavor resolute, active prospective arm) with 1st generation ZES (Endeavor Sprint, 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 Resolute Endeavor Resolute stents Prospective recruitment of Resolute arm will start in March 2009 Endeavor Endeavor Sprint stent The retrospective recruiting period of Endeavor arm comprises a fixed 2-year time between January 2006 and December 2008. The patients, who were treated with Endeavor in that period, will be enrolled if they agree to participate in this study.
- 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 (19)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Chonbuk National Univesity Hospital
🇰🇷Iksan, Korea, Republic of
St. Vincent's Hospital
🇰🇷Suwon, Korea, Republic of
National Health Insurance Corporation Ilsan Hospital
🇰🇷Ilsan, Korea, Republic of
Inha University Hospital
🇰🇷Inchon, Korea, Republic of
Bundang CHA Medical Center
🇰🇷Seongnam, Korea, Republic of
Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of
Seoul Boramae Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Hospital
🇰🇷Seoul, Korea, Republic of
Gachon Kil Medical Center
🇰🇷Inchon, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Gangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Yongnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of