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

Coronary Artery Disease Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT00698607
• Study type: Interventional
• Source: Seoul National University Hospital
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 2008
• Completion date: April 2014