Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments xience/promus, cypher
Sponsor Seoul National University Hospital
Collaborator Abbott
Start date April 2009
End date April 2011
Trial size 4000 participants
Trial identifier NCT00960648, EXCELLENT-REGISTRY

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Active prospective registration of patients receiving everolimus eluting stent
xience/promus EES
Active prospective registration of patients receiving everolimus-eluting stent
Retrospective historical controls that received sirolimus-eluting stent
cypher SES
Retrospective historical controls that received sirolimus-eluting stent

Primary Outcomes

Measure
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
time frame: 12 months

Secondary Outcomes

Measure
In-stent & In-segment Late Loss
time frame: 9 months
Stent Thrombosis
time frame: 1 year
Target Vessel Failure (composite of cardiac death, MI, and TVR)
time frame: 12 months
Any death, cardiac death, MI, TLR, TVR
time frame: 1 year
Composite rate of cardiac death and any MI
time frame: 1 year
Composite rate of all death and any MI
time frame: 1 year
Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization
time frame: 1 year
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
time frame: 1 year
Clinical device and procedural success
time frame: During the health care facility stay

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title EXCELLENT (Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing) Registry
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.