EXCELLENT (Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing) Registry
Overview
- Phase
- Not Applicable
- Intervention
- Xience/Promus
- Conditions
- Coronary Artery Disease
- Sponsor
- Seoul National University Hospital
- Enrollment
- 3056
- Locations
- 36
- Primary Endpoint
- Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
- Status
- Completed
- Last Updated
- 5 days ago
Overview
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).
Investigators
Hyo-Soo Kim
Investigator
Seoul National University Hospital
Eligibility Criteria
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 exclusion criteria for this registry.
Arms & Interventions
Xience/Promus
Active prospective registration of patients receiving everolimus eluting stent
Intervention: Xience/Promus
Cypher
Retrospective historical controls that received sirolimus-eluting stent
Intervention: Cypher
Outcomes
Primary Outcomes
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
Time Frame: 12 months
Secondary Outcomes
- 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)