Clinical trial NCT00960648: Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting
Official title: EXCELLENT (Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing) Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Everolimus
Sirolimus
Drug eluting stent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
name: Boston Scientific Corporation
First posted: 2009-08-18
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 4000 patients derived from a population of patients receiving percutaneous coronary intervention for ischemic heart disease will be enrolled in the present registry.

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).


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.

Primary outcomes:
measure: Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
timeFrame: 12 months
Secondary outcomes:
measure: In-stent & In-segment Late Loss
timeFrame: 9 months
measure: Stent Thrombosis
timeFrame: 1 year
measure: Target Vessel Failure (composite of cardiac death, MI, and TVR)
timeFrame: 12 months
measure: Any death, cardiac death, MI, TLR, TVR
timeFrame: 1 year
measure: Composite rate of cardiac death and any MI
timeFrame: 1 year
measure: Composite rate of all death and any MI
timeFrame: 1 year
measure: Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization
timeFrame: 1 year
measure: Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
timeFrame: 1 year
measure: Clinical device and procedural success
timeFrame: During the health care facility stay
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Chonju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Kwangju Veterans Hospital
city: Iksan
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Inchon
country: Korea, Republic of
facility: Gachon Kil Medical Center
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Medical Center
city: Suncheon
country: Korea, Republic of
facility: St. Carollo Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Soo Kim, MD,PhD
role: STUDY_CHAIR
References: