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Coronary Artery DiseasePhase 4EXCELLENTNCT00698607

Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing

A Phase 4 study testing Everolimus-eluting stent (Xience or Promus), Sirolimus-eluting stent (Cypher) and 6-month clopidogrel therapy in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objectives 1. To evaluate the safety and long-term effectiveness of coronary stenting with the Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting coronary stent system(SECSS) (CypherTM, Cordis… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Everolimus-eluting stent (Xience or Promus), Sirolimus-eluting stent (Cypher) and 6-month clopidogrel therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,466 participants
Where
1 siteSouth Korea
Study dates
Jun 2008to Apr 2014
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

General Inclusion Criteria:

  1. Subject must be at least 18 years of age.
  2. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the XIENCE V EECS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
  3. Subject must have significant coronary artery stenosis (>50% by visual estimate)
  4. Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia. In subjects with coronary artery stenosis > 75%, evidence of myocardial ischemia does not have to be documented.
  5. Subjects must be an acceptable candidate for Coronary Artery Bypass Graft (CABG) surgery.

Angiographically Inclusion Criteria

  1. Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.
  2. Target lesion(s) must be amenable for percutaneous coronary intervention

General Exclusion Criteria:

  1. The patient has a known hypersensitivity or contraindication to any of the following medications (heparin, aspirin, clopidogrel, sirolimus, everolimus, Contrast media
  2. Systemic (intravenous) Sirolimus, everolimus use within 12 months.
  3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
  4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
  5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  6. Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
  7. An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.
  8. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  9. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  10. Patients who have received any stent implantation in the target vessel prior to enrollment.
  11. Patients with LVEF<25% or those with cardiogenic shock
  12. Patients with myocardial infarction within 72 hours
  13. Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
  14. Severe hepatic dysfunction (AST and ALT: 3 times upper normal reference values).

Angiographic Exclusion Criteria

  1. Patients with significant left main coronary artery stenosis
  2. Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
  3. Target lesions with chronic total occlusion
  4. True bifurcation lesions requiring two stents

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: Comparison of the Efficacy of Everolimus-Eluting Versus Sirolimus-Eluting Stent for Coronary Lesions

Objectives

  1. To evaluate the safety and long-term effectiveness of coronary stenting with the Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting coronary stent system(SECSS) (CypherTM, Cordis Johnson \& Johnson, Warren, NJ) in the treatment of coronary stenosis.
  2. To evaluate the safety and efficacy of 6-month clopidogrel therapy compared with 12-month clopidogrel therapy.
Read more

Study Design: Prospective, open label, two-arm, randomized multi-center trial to test the non-inferiority of EECSS compared with the SECSS, and to test the non-inferiority of 6 months duration compared with 12 months duration of clopidogrel therapy. Patients will be randomized in a two by two factorial manner according to the type of drug eluting stent (EECSS vs. SECSS) and the duration of dual anti-platelet therapy (6 months vs. 12 months). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length ≥ 28mm)

Patient Enrollment: 1,372 patients enrolled at 17 centers in Korea.

Patient Follow-Up: Clinical follow-up will occur at 1, 3, and 9 months, and at 1, 2, 3, 4, and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office visits.

Primary Endpoint

  • In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.
  • Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy

Secondary Endpoint

  • All Death
  • Cardiac death
  • Myocardial infarction
  • Target vessel revascularization (TVR) (all and ischemia-driven)
  • Target lesion revascularization (TLR) (all and ischemia-driven)
  • Stent thrombosis
  • Acute success (device, lesion, and procedure)
  • Bleeding
  • Cerebrovascular accident
  • In-stent LL at 9 months
  • Angiographic pattern of restenosis at 9-month angiographic follow-up
  • In-stent and in-segment % diameter stenosis (%DS) at 9 months
  • In-stent % volume obstruction (%VO) at 9 months
  • Incomplete stent apposition post index procedure
  • Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months
Being tested
Everolimus-eluting stent (Xience or Promus), Sirolimus-eluting stent (Cypher), 6-month clopidogrel therapy, 12-month clopidogrel therapy
Keywords
Everolimus, Sirolimus, drug eluting stent, Clopidogrel
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.

  • Everolimus-eluting stent (Xience or Promus)Device

    Also called Xience, Promus

    Use everolimus-eluting stent in the treatment of coronary stenosis

  • Sirolimus-eluting stent (Cypher)Device

    Also called Cypher

    Use sirolimus-eluting stent in the treatment of coronary stenosis

  • 6-month clopidogrel therapyDrug

    Also called Plavix

    Use clopidogrel for 6 months

  • 12-month clopidogrel therapyDrug

    Also called Plavix

    Use clopidogrel for 12 months

Study groups in NCT00698607
Study groupRoleWhat they receive
E6ExperimentalEverolimus-eluting stent 6-month clopidogrel therapy
Receives: Device: Everolimus-eluting stent (Xience or Promus); Drug: 6-month clopidogrel therapy
S6Active comparatorSirolimus-eluting stent 6-month clopidogrel therapy
Receives: Device: Sirolimus-eluting stent (Cypher); Drug: 6-month clopidogrel therapy
E12ExperimentalEverolimus-eluting stent 12-month clopidogrel therapy
Receives: Device: Everolimus-eluting stent (Xience or Promus); Drug: 12-month clopidogrel therapy
S12Active comparatorSirolimus-eluting stent 12-month clopidogrel therapy
Receives: Device: Sirolimus-eluting stent (Cypher); Drug: 12-month clopidogrel therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.

    Measured: 9 months

  2. Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy

    Measured: 12 months

Secondary outcomes (15)

  1. All death

    Measured: 5 years

  2. Cardiac death

    Measured: 5 Years

  3. Myocardial infarction

    Measured: 5 years

  4. Target vessel revascularization (TVR) (all and ischemia-driven)

    Measured: 5 years

  5. Target lesion revascularization (TLR) (all and ischemia-driven)

    Measured: 5 years

  6. Stent thrombosis

    Measured: 5 years

  7. Acute success (device, lesion, and procedure)

    Measured: Index procedure

  8. Bleeding

    Measured: 5 years

  9. Cerebrovascular accident

    Measured: 5 years

  10. In-stent LL at 9 months

    Measured: 9 months

  11. Angiographic pattern of restenosis at 9-month angiographic follow-up

    Measured: 9 months

  12. In-stent and in-segment % diameter stenosis (%DS) at 9 months

    Measured: 9 months

  13. In-stent % volume obstruction (%VO) at 9 months

    Measured: 9 months

  14. Incomplete stent apposition post index procedure

    Measured: Index procedure

  15. Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionDec 2013
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
1,466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00698607
Sponsor's protocol ID
EXCELLENT
Acronym
EXCELLENT
Status last verified
Apr 2026
First submitted
15 Jun 2008
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Lee JM, Park KW, Han JK, Yang HM, Kang HJ, Koo BK, Bae JW, Woo SI, Park JS, Jin DK, Jeon DW, Oh SK, Park JS, Kim DI, Hyon MS, Jeon HK, Lim DS, Kim MG, Rha SW, Her SH, Hwang JY, Kim S, Choi YJ, Kang JH, Moon KW, Jang Y, Kim HS. Three-year patient-related and stent-related outcomes of second-generation everolimus-eluting Xience V stents versus zotarolimus-eluting resolute stents in real-world practice (from the Multicenter Prospective EXCELLENT and RESOLUTE-Korea Registries). Am J Cardiol. 2014 Nov 1;114(9):1329-38. doi: 10.1016/j.amjcard.2014.07.065. Epub 2014 Aug 12.

    PubMed 25217457

  • Jang JY, Jung HW, Lee BK, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Kwon HM, Jang Y. Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation. Cardiovasc Drugs Ther. 2021 Apr;35(2):343-352. doi: 10.1007/s10557-020-07008-7.

    PubMed 32588238

  • Kang J, Han JK, Kang DY, Zheng C, Yang HM, Park KW, Kang HJ, Koo BK, Kim HS. SYNTAX Score and SYNTAX Score II Can Predict the Clinical Outcomes of Patients with Left Main and/or 3-Vessel Disease Undergoing Percutaneous Coronary Intervention in the Contemporary Cobalt-Chromium Everolimus-Eluting Stent Era. Korean Circ J. 2020 Jan;50(1):22-34. doi: 10.4070/kcj.2019.0097. Epub 2019 Sep 30.

    PubMed 31642213

  • Jang JY, Shin DH, Kim JS, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Park KW, Gwon HC, Kim HS, Jang Y. Optimal duration of DAPT after second-generation drug-eluting stent in acute coronary syndrome. PLoS One. 2018 Nov 26;13(11):e0207386. doi: 10.1371/journal.pone.0207386. eCollection 2018.

    PubMed 30475845

  • Park KW, Rhee TM, Kang HJ, Koo BK, Gwon HC, Yoon JH, Lim DS, Chae IH, Han KR, Ahn T, Jeong MH, Jeon DW, Jang YS, Kim HS. Randomized Prospective Comparison of Everolimus-Eluting vs. Sirolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention - 3-Year Clinical Outcomes of the EXCELLENT Randomized Trial. Circ J. 2018 May 25;82(6):1566-1574. doi: 10.1253/circj.CJ-17-0677. Epub 2017 Sep 30.

    PubMed 28966335

  • Ko YG, Shin DH, Kim JS, Kim BK, Choi D, Hong MK, Gwon HC, Ahn T, Chae IH, Yoon JH, Kim HS, Jang Y; EXCELLENT investigators. Comparison of neointimal hyperplasia and peri-stent vascular remodeling after implantation of everolimus-eluting versus sirolimus-eluting stents: intravascular ultrasound results from the EXCELLENT study. Int J Cardiovasc Imaging. 2013 Aug;29(6):1229-36. doi: 10.1007/s10554-013-0199-5. Epub 2013 Mar 3.

    PubMed 23456359

  • Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation. 2012 Jan 24;125(3):505-13. doi: 10.1161/CIRCULATIONAHA.111.059022. Epub 2011 Dec 16.

    PubMed 22179532

  • Park KW, Chae IH, Lim DS, Han KR, Yang HM, Lee HY, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Jo SH, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Gwon HC, Jang YS, Kim HS. Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: the EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) randomized trial. J Am Coll Cardiol. 2011 Oct 25;58(18):1844-54. doi: 10.1016/j.jacc.2011.07.031.

    PubMed 22018294

  • Park KW, Yoon JH, Kim JS, Hahn JY, Cho YS, Chae IH, Gwon HC, Ahn T, Oh BH, Park JE, Shim WH, Shin EK, Jang YS, Kim HS. Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial: study design and rationale of a Korean multicenter prospective randomized trial. Am Heart J. 2009 May;157(5):811-817.e1. doi: 10.1016/j.ahj.2009.02.008.

    PubMed 19376305

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Everolimus-eluting stent (Xience or Promus), Sirolimus-eluting stent (Cypher) and 6-month clopidogrel therapy in people with Coronary Artery Disease, run by Seoul National University Hospital at 1 site 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?

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 1 site 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS. (time frame: 9 months). The study lists 2 primary outcomes in all. 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 NCT00698607, which also lists 9 linked publications.

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.

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