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

April 22, 2026 updated by: Hyo-Soo Kim, Seoul National University Hospital

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1466

Phase

  • Phase 4

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

  • South Korea
      • Seoul, South Korea, 110-744
        • Seoul National University 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E6
Everolimus-eluting stent 6-month clopidogrel therapy
Device: Everolimus-eluting stent (Xience or Promus)
Use everolimus-eluting stent in the treatment of coronary stenosis
Other Names:
  • Promus
  • Xience
Drug: 6-month clopidogrel therapy
Use clopidogrel for 6 months
Other Names:
  • Plavix
Active Comparator: S6
Sirolimus-eluting stent 6-month clopidogrel therapy
Drug: 6-month clopidogrel therapy
Use clopidogrel for 6 months
Other Names:
  • Plavix
Device: Sirolimus-eluting stent (Cypher)
Use sirolimus-eluting stent in the treatment of coronary stenosis
Other Names:
  • Cypher
Experimental: E12
Everolimus-eluting stent 12-month clopidogrel therapy
Device: Everolimus-eluting stent (Xience or Promus)
Use everolimus-eluting stent in the treatment of coronary stenosis
Other Names:
  • Promus
  • Xience
Drug: 12-month clopidogrel therapy
Use clopidogrel for 12 months
Other Names:
  • Plavix
Active Comparator: S12
Sirolimus-eluting stent 12-month clopidogrel therapy
Device: Sirolimus-eluting stent (Cypher)
Use sirolimus-eluting stent in the treatment of coronary stenosis
Other Names:
  • Cypher
Drug: 12-month clopidogrel therapy
Use clopidogrel for 12 months
Other Names:
  • Plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.
Time Frame: 9 months
9 months
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
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Stent thrombosis
Time Frame: 5 years
5 years
All death
Time Frame: 5 years
5 years
Myocardial infarction
Time Frame: 5 years
5 years
Bleeding
Time Frame: 5 years
5 years
Cerebrovascular accident
Time Frame: 5 years
5 years
Cardiac death
Time Frame: 5 Years
5 Years
Target vessel revascularization (TVR) (all and ischemia-driven)
Time Frame: 5 years
5 years
Target lesion revascularization (TLR) (all and ischemia-driven)
Time Frame: 5 years
5 years
Acute success (device, lesion, and procedure)
Time Frame: Index procedure
Index procedure
In-stent LL at 9 months
Time Frame: 9 months
9 months
Angiographic pattern of restenosis at 9-month angiographic follow-up
Time Frame: 9 months
9 months
In-stent and in-segment % diameter stenosis (%DS) at 9 months
Time Frame: 9 months
9 months
In-stent % volume obstruction (%VO) at 9 months
Time Frame: 9 months
9 months
Incomplete stent apposition post index procedure
Time Frame: Index procedure
Index procedure
Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Boston Scientific Corporation
Abbott

Investigators

  • Study Chair: Yangsoo Jang, MD, PhD, Yonsei University
  • Study Chair: Jung-Han Yoon, MD, PhD, Yonsei Univercity Wonju hospital
  • Study Chair: Ahn Tae-Hoon, MD, PhD, Gachon Kil Medical Center
  • Study Chair: Hyun-Cheol Kwon, MD, PhD, Samsung Medical Center
  • Principal Investigator: Young-Jin Choi, MD, PhD, Hallym University Medical Center
  • Principal Investigator: Kyoo-Rok Han, MD, PhD, Kandong Sacred heart Hospital
  • Principal Investigator: Si-Hoon Park, MD, PhD, Ewha Women's University Hospital
  • Principal Investigator: Myeong-Ho Chung, MD, PhD, Chonnam National University Hospital
  • Principal Investigator: Hyuk-Moon Kwon, MD, PhD, Yonsei University
  • Principal Investigator: Dong-Woon Chun, MD, PhD, National Health Insurance Service Ilsan Hospital
  • Principal Investigator: Byung-Ok Kim, MD, PhD, Inje University Sanggye Hospital
  • Principal Investigator: Do-Sun Lim, MD, PhD, Korea University Anam Hospital
  • Principal Investigator: Taek-Jong Hong, MD, PhD, Pusan National University Hospital
  • Principal Investigator: Woo-Young Chung, MD, PhD, Borame Hospital
  • Principal Investigator: Jae-Hun Chung, MD, PhD, Hallym University Kangnam Sacred Heart Hospital
  • Study Chair: Hyo-Soo Kim, MD, PhD, Seoul National University Hospital
  • Study Chair: In-Ho Chae, MD, PhD, Seoul National University Bundang 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.

General Publications

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)

June 1, 2008

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 15, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimated)

June 17, 2008

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

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.

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