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NCT00960648 Clinical Trial

Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting

Coronary Artery Disease Clinical Trial

Official title:
EXCELLENT (Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing) Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00960648
Other study ID # EXCELLENT-REGISTRY
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 14, 2009
Last updated June 28, 2010
Start date April 2009

Study information
Verified date June 2010
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 4000
Est. completion date
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Xience/Promus
Active prospective registration of patients receiving everolimus-eluting stent
• Cypher
Retrospective historical controls that received sirolimus-eluting stent

Locations
Country Name City State
Korea, Republic of Dankook University Hospital Cheonan
Korea, Republic of Soon Chun Hyang University Hospital Cheonan Cheonan
Korea, Republic of Chungbuk National University Hospital Chonju
Korea, Republic of Kwangju Veterans Hospital Gwangju
Korea, Republic of Chonbuk National University Hospital Iksan
Korea, Republic of Wonkwang University Hospital Iksan
Korea, Republic of Inje University Ilsan Paik Hospital Ilsan
Korea, Republic of Gachon Kil Medical Center Inchon
Korea, Republic of Presbyterian Medical Center Jeonju
Korea, Republic of Gyeongsang National University Hospital Jinju
Korea, Republic of Inje University Pusan Paik Hospital Pusan
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Kyung Hee University Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Yonsei University Medical Center Seoul
Korea, Republic of St. Carollo Hospital Suncheon

Sponsors (3)
Lead Sponsor Collaborator
Seoul National University Hospital Abbott, Boston Scientific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization) 12 months Yes
Secondary In-stent & In-segment Late Loss 9 months Yes
Secondary Stent Thrombosis 1 year Yes
Secondary Target Vessel Failure (composite of cardiac death, MI, and TVR) 12 months Yes
Secondary Any death, cardiac death, MI, TLR, TVR 1 year Yes
Secondary Composite rate of cardiac death and any MI 1 year Yes
Secondary Composite rate of all death and any MI 1 year Yes
Secondary Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization 1 year Yes
Secondary Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy 1 year Yes
Secondary Clinical device and procedural success During the health care facility stay Yes
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