Comparison of Zotarolimus-Eluting Stent vs Sirolimus-Eluting Stent for Diabetic Patients

Phase 4

Completed

• Conditions: Coronary Artery Disease; Diabetes
• Interventions: Device: Cypher stent; Device: Endeavor Resolute stent

• Registration Number: NCT01186107
• Lead Sponsor: Seung-Jung Park

Brief Summary

The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.

Detailed Description

Prospective, two arms, single blind, randomized multi-center trial of 380 patients enrolled at 24 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Endeavor Resolute stent vs. b) Cypher select. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Primary Completion: 2012-12
• Study Completion: 2013-07
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-28
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• Diabetic patients with angina and documented ischemia
• Patients who are eligible for intracoronary stenting
• De novo lesion
• Percent diameter stenosis ≥50%
• Reference vessel size ≥ 2.5 mm by visual estimation

Exclusion Criteria

• History of bleeding diathesis or coagulopathy
• Pregnant state
• Known hypersensitivity or contra-indication to contrast agent and heparin
• Limited life-expectancy (less than 1 year)
• Acute ST elevation myocardial infarction on admission
• Characteristics of lesion Left main disease In-stent restenosis Graft vessels
• Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)
• Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal
• Renal dysfunction, creatinine ≥ 2.0mg/dL
• Contraindication to aspirin, clopidogrel or cilostazol
• Left ventricular ejection fraction <30%
• Patients who are actively participating in another drug or device - investigational study, which have not completed the primary endpoint follow- up period.
• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cypher stent	Cypher stent	sirolimus-eluting stent
Endeavor Resolute stent	Endeavor Resolute stent	zotarolimus-eluting stent

Primary Outcome Measures

Name	Time	Method
Angiographic in-segment late loss	9-month angiographic follow-up

Secondary Outcome Measures

Name	Time	Method
Death (all-cause and cardiac)	at 12 months
myocardial infarction	at 12 months
stent thrombosis	at 12 months
target-lesion revascularization	at 12 months
target-vessel revascularization	at 12 months

Trial Locations

Locations (11)

Soonchunhyang University Bucheon Hospital; 🇰🇷 Bucheon, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Gyeong-gi, Korea, Republic of

Kangwon University Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Pusan, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

GangNeung Asan Hospital; 🇰🇷 GangNeung, Korea, Republic of

Daejeon St Mary's Hospital Catholic University; 🇰🇷 Daejeon, Korea, Republic of

Seoul Veterans Hospital; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang University Cheonan Hospital; 🇰🇷 Cheonan, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of