Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments everolimus-eluting stent (xience or promus), sirolimus-eluting stent (cypher), 6-month clopidogrel therapy, 12-month clopidogrel therapy
Phase phase 4
Sponsor Seoul National University Hospital
Collaborator Abbott
Start date June 2008
End date April 2010
Trial size 1466 participants
Trial identifier NCT00698607, EXCELLENT

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 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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Everolimus-eluting stent 6-month clopidogrel therapy
everolimus-eluting stent (xience or promus) Xience
Use everolimus-eluting stent in the treatment of coronary stenosis
6-month clopidogrel therapy Plavix
Use clopidogrel for 6 months
(Active Comparator)
Sirolimus-eluting stent 6-month clopidogrel therapy
sirolimus-eluting stent (cypher) Cypher
Use sirolimus-eluting stent in the treatment of coronary stenosis
6-month clopidogrel therapy Plavix
Use clopidogrel for 6 months
(Experimental)
Everolimus-eluting stent 12-month clopidogrel therapy
everolimus-eluting stent (xience or promus) Xience
Use everolimus-eluting stent in the treatment of coronary stenosis
12-month clopidogrel therapy Plavix
Use clopidogrel for 12 months
(Active Comparator)
Sirolimus-eluting stent 12-month clopidogrel therapy
sirolimus-eluting stent (cypher) Cypher
Use sirolimus-eluting stent in the treatment of coronary stenosis
12-month clopidogrel therapy Plavix
Use clopidogrel for 12 months

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Comparison of the Efficacy of Everolimus-Eluting Versus Sirolimus-Eluting Stent for Coronary Lesions
Principal investigator Young-Jin Choi, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.