Seoul National University Hospital
Seoul, 110-744, South Korea
NCT Number: NCT00698607
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 4
Seoul, 110-744, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
General Inclusion Criteria:
Angiographically Inclusion Criteria
General Exclusion Criteria:
Angiographic Exclusion Criteria
Use everolimus-eluting stent in the treatment of coronary stenosis
Other names: Xience, Promus
Use sirolimus-eluting stent in the treatment of coronary stenosis
Other names: Cypher
Use clopidogrel for 6 months
Other names: Plavix
Use clopidogrel for 12 months
Other names: Plavix
Time frame: 9 months
Time frame: 12 months
Time frame: 5 years
Time frame: 5 Years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: 5 years
Time frame: Index procedure
Time frame: 5 years
Time frame: 5 years
Time frame: 9 months
Time frame: 9 months
Time frame: 9 months
Time frame: 9 months
Time frame: Index procedure
Time frame: 9 months
Seoul National University Hospital
Other
Comparison of the Efficacy of Everolimus-Eluting Versus Sirolimus-Eluting Stent for Coronary Lesions
Acronym: EXCELLENT
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.
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