Coronary Artery DiseaseNCT00960648
Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 18 sites in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Xience/Promus and Cypher
- Type of treatment
- Medical device
- How many people
- 3,056 participants
- Where
- 18 sitesSouth Korea
- Study dates
- Apr 2008to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- There are no exclusion criteria for this registry.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
Dankook University Hospital
Cheonan
Soon Chun Hyang University Hospital Cheonan
Cheonan
Chungbuk National University Hospital
Cheongju-si
Kwangju Veterans Hospital
Gwangju
Chonbuk National University Hospital
Iksan
Wonkwang University Hospital
Iksan
Inje University Ilsan Paik Hospital
Ilsan
Gachon Kil Medical Center
Inchon
Presbyterian Medical Center
Jeonju
Gyeongsang National University Hospital
Jinju
Inje University Pusan Paik Hospital
Pusan
Seoul National University Bundang Hospital
Seongnam
Gangnam Severance Hospital
Seoul
Kyung Hee University Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Yonsei University Medical Center
Seoul
St. Carollo Hospital
Suncheon
About this study
Official title: 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).
- Conditions
- Coronary Artery Disease
- Being tested
- Xience/Promus, Cypher
- Keywords
- Everolimus, Sirolimus, Drug eluting stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xience/PromusDevice
Also called EES
Active prospective registration of patients receiving everolimus-eluting stent
CypherDevice
Also called SES
Retrospective historical controls that received sirolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Xience/Promus | Active prospective registration of patients receiving everolimus eluting stent Receives: Device: Xience/Promus | |
| Cypher | Retrospective historical controls that received sirolimus-eluting stent Receives: Device: Cypher |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
Measured: 12 months
Secondary outcomes (9)
In-stent & In-segment Late Loss
Measured: 9 months
Stent Thrombosis
Measured: 1 year
Target Vessel Failure (composite of cardiac death, MI, and TVR)
Measured: 12 months
Any death, cardiac death, MI, TLR, TVR
Measured: 1 year
Composite rate of cardiac death and any MI
Measured: 1 year
Composite rate of all death and any MI
Measured: 1 year
Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization
Measured: 1 year
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
Measured: 1 year
Clinical device and procedural success
Measured: During the health care facility stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startApr 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,056 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Boston Scientific Corporation
- Responsible party
- Principal investigator, Hyo-Soo Kim, Seoul National University Hospital
- Investigators
- Hyo-Soo Kim, MD,PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960648
- Sponsor's protocol ID
- EXCELLENT-REGISTRY
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2009
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee JM, Hahn JY, Kang J, Park KW, Chun WJ, Rha SW, Yu CW, Jeong JO, Jeong MH, Yoon JH, Jang Y, Tahk SJ, Gwon HC, Koo BK, Kim HS. Differential Prognostic Effect Between First- and Second-Generation Drug-Eluting Stents in Coronary Bifurcation Lesions: Patient-Level Analysis of the Korean Bifurcation Pooled Cohorts. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1318-1331. doi: 10.1016/j.jcin.2015.05.014.
PubMed 26315734
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXCELLENT (Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing) Registry
- ClinicalTrials.gov ID
- NCT00960648
- Acronym / sponsor ID
- EXCELLENT-REGISTRY
- Conditions
- Coronary Artery Disease
- Keywords
- Everolimus, Sirolimus, Drug eluting stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,056 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Abbott, Boston Scientific Corporation
- Study start
- Apr 2008 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xience/Promus | – | Device: Xience/PromusActive prospective registration of patients receiving everolimus eluting stent |
| Cypher | – | Device: CypherRetrospective historical controls that received sirolimus-eluting stent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xience/PromusAlso: EESActive prospective registration of patients receiving everolimus-eluting stent | Device | Xience/Promus |
| CypherAlso: SESRetrospective historical controls that received sirolimus-eluting stent | Device | Cypher |
Primary outcome
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
Time frame: 12 months
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Results publication: PubMed 26315734Lee JM, Hahn JY, Kang J, Park KW, Chun WJ, Rha SW, Yu CW, Jeong JO, Jeong MH, Yoon JH, Jang Y, Tahk SJ, Gwon HC, Koo BK, Kim HS. Differential Prognostic Effect Between First- and Second-Generation Drug-Eluting Stents in Coronary Bifurcation Lesions: Patient-Level Analysis of the Korean Bifurcation Pooled Cohorts. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1318-1331. doi: 10.1016/j.jcin.2015.05.014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyo-Soo Kim, MD,PhD study chair
Seoul National University Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Seoul National University Hospital at 18 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00960648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.