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.

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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2010

Intervention(s) in this Clinical Trial

• Device: Everolimus-eluting stent (Xience or Promus)
  • Use everolimus-eluting stent in the treatment of coronary stenosis
• Device: Sirolimus-eluting stent (Cypher)
  • Use sirolimus-eluting stent in the treatment of coronary stenosis
• Drug: 6-month clopidogrel therapy
  • Use clopidogrel for 6 months
• Drug: 12-month clopidogrel therapy
  • Use clopidogrel for 12 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: E6
  • Everolimus-eluting stent 6-month clopidogrel therapy
• Active Comparator: S6
  • Sirolimus-eluting stent 6-month clopidogrel therapy
• Experimental: E12
  • Everolimus-eluting stent 12-month clopidogrel therapy
• Active Comparator: S12
  • Sirolimus-eluting stent 12-month clopidogrel therapy

Primary Measures

• In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS.
  • Time Frame: 9 months
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes

Secondary Measures

• All death
  • Time Frame: 5 years
    Safety Issue?: Yes
• Cardiac death
  • Time Frame: 5 Years
    Safety Issue?: Yes
• Myocardial infarction
  • Time Frame: 5 years
    Safety Issue?: Yes
• Target vessel revascularization (TVR) (all and ischemia-driven)
  • Time Frame: 5 years
    Safety Issue?: Yes
• Target lesion revascularization (TLR) (all and ischemia-driven)
  • Time Frame: 5 years
    Safety Issue?: Yes
• Stent thrombosis
  • Time Frame: 5 years
    Safety Issue?: Yes
• Acute success (device, lesion, and procedure)
  • Time Frame: Index procedure
    Safety Issue?: Yes
• Bleeding
  • Time Frame: 5 years
    Safety Issue?: Yes
• Cerebrovascular accident
  • Time Frame: 5 years
    Safety Issue?: Yes
• In-stent LL at 9 months
  • Time Frame: 9 months
    Safety Issue?: Yes
• Angiographic pattern of restenosis at 9-month angiographic follow-up
  • Time Frame: 9 months
    Safety Issue?: Yes
• In-stent and in-segment % diameter stenosis (%DS) at 9 months
  • Time Frame: 9 months
    Safety Issue?: Yes
• In-stent % volume obstruction (%VO) at 9 months
  • Time Frame: 9 months
    Safety Issue?: Yes
• Incomplete stent apposition post index procedure
  • Time Frame: Index procedure
    Safety Issue?: No
• Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months
  • Time Frame: 9 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Seoul National University Hospital

Overall Clinical Trial Officials and Contacts

Hyo-Soo Kim, MD, PhD Study Chair Seoul National University Hospital  

Overall Contact: Kyung-Woo Park, MD, PhD 82-2-2072-0244 kwparkmd@snu.ac.kr

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00698607

Study ID Number: EXCELLENT

ClinicalTrials.gov Identifier: NCT00698607

Health Authority: South Korea: Institutional Review Board