Coronary Artery Disease
Conditions
Keywords
Zotarolimus, Drug eluting stent, Endeavor Resolute
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).
Interventions
DEVICEEndeavor Resolute stents
2nd generation ZES
DEVICEEndeavor Sprint stent
1st generation ZES
Sponsors
Medtronic
Seoul National University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| In-stent & In-segment Late Loss | 9 months |
| 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 |
| Composite rate of all death and any MI | 1 year |
Countries
South Korea
Contacts
Primary ContactKyung-Woo Park, MD, PhD
Backup ContactIl-Young Oh, MD
Outcome results
None listed