- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00960648
Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting
April 22, 2026 updated by: Hyo-Soo Kim, Seoul National University Hospital
EXCELLENT (Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing) Registry
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
3056
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cheonan, South Korea
- Soon Chun Hyang University Hospital Cheonan
-
Cheonan, South Korea
- Dankook University Hospital
-
Cheongju-si, South Korea
- Chungbuk National University Hospital
-
Gwangju, South Korea
- Kwangju Veterans Hospital
-
Iksan, South Korea
- Wonkwang University Hospital
-
Iksan, South Korea
- Chonbuk National University Hospital
-
Ilsan, South Korea
- Inje University Ilsan Paik Hospital
-
Inchon, South Korea
- Gachon Kil Medical Center
-
Jeonju, South Korea
- Presbyterian Medical Center
-
Jinju, South Korea
- Gyeongsang National University Hospital
-
Pusan, South Korea
- Inje University Pusan Paik Hospital
-
Seongnam, South Korea
- Seoul National University Bundang Hospital
-
Seoul, South Korea
- Samsung Medical Center
-
Seoul, South Korea
- Seoul National University Hospital
-
Seoul, South Korea
- Gangnam Severance Hospital
-
Seoul, South Korea
- Kyung Hee University Medical Center
-
Seoul, South Korea
- Yonsei University Medical Center
-
Suncheon, South Korea
- St. Carollo Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Xience/Promus
Active prospective registration of patients receiving everolimus eluting stent
|
Active prospective registration of patients receiving everolimus-eluting stent
Other Names:
|
|
Cypher
Retrospective historical controls that received sirolimus-eluting stent
|
Retrospective historical controls that received sirolimus-eluting stent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
In-stent & In-segment Late Loss
Time Frame: 9 months
|
9 months
|
|
Stent Thrombosis
Time Frame: 1 year
|
1 year
|
|
Target Vessel Failure (composite of cardiac death, MI, and TVR)
Time Frame: 12 months
|
12 months
|
|
Any death, cardiac death, MI, TLR, TVR
Time Frame: 1 year
|
1 year
|
|
Composite rate of cardiac death and any MI
Time Frame: 1 year
|
1 year
|
|
Composite rate of all death and any MI
Time Frame: 1 year
|
1 year
|
|
Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization
Time Frame: 1 year
|
1 year
|
|
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
Time Frame: 1 year
|
1 year
|
|
Clinical device and procedural success
Time Frame: During the health care facility stay
|
During the health care facility stay
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Hyo-Soo Kim, MD,PhD, Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2008
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
August 14, 2009
First Submitted That Met QC Criteria
August 17, 2009
First Posted (Estimated)
August 18, 2009
Study Record Updates
Last Update Posted (Actual)
April 27, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXCELLENT-REGISTRY
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.