Skip to main content
OpenTrials
Completed

NCT Number: NCT00698607

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

General Inclusion Criteria:

  • Subject must be at least 18 years of age.
  • 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.
  • Subject must have significant coronary artery stenosis (>50% by visual estimate)
  • 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.
  • Subjects must be an acceptable candidate for Coronary Artery Bypass Graft (CABG) surgery.

Angiographically Inclusion Criteria

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

General Exclusion Criteria:

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

Angiographic Exclusion Criteria

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

Treatment and study plan

Everolimus-eluting stent (Xience or Promus)

Device

Use everolimus-eluting stent in the treatment of coronary stenosis

Other names: Xience, Promus

Sirolimus-eluting stent (Cypher)

Device

Use sirolimus-eluting stent in the treatment of coronary stenosis

Other names: Cypher

6-month clopidogrel therapy

Drug

Use clopidogrel for 6 months

Other names: Plavix

12-month clopidogrel therapy

Drug

Use clopidogrel for 12 months

Other names: Plavix

Primary outcomes

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

    Time frame: 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

    Time frame: 12 months

Secondary outcomes

  1. All death

    Time frame: 5 years

  2. Cardiac death

    Time frame: 5 Years

  3. Myocardial infarction

    Time frame: 5 years

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

    Time frame: 5 years

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

    Time frame: 5 years

  6. Stent thrombosis

    Time frame: 5 years

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

    Time frame: Index procedure

  8. Bleeding

    Time frame: 5 years

  9. Cerebrovascular accident

    Time frame: 5 years

  10. In-stent LL at 9 months

    Time frame: 9 months

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

    Time frame: 9 months

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

    Time frame: 9 months

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

    Time frame: 9 months

  14. Incomplete stent apposition post index procedure

    Time frame: Index procedure

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

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Abbott
  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: EXCELLENT

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Jun 17, 2008
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.